Drug factory · FDA FEI 3008694072

Winder Laboratories, LLC

712 PATRICK INDUSTRIAL LANE, Winder, GA, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Aug 5, 2025 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not followed.
• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not followed.
• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not followed.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
• Sampling and testing plans not followed 21 CFR 211.165(c)
  Written procedures for sampling and testing plans are not followed for each drug product.
• Sampling and testing plans not followed 21 CFR 211.165(c)
  Written procedures for sampling and testing plans are not followed for each drug product.
• Sampling and testing plans not followed 21 CFR 211.165(c)
  Written procedures for sampling and testing plans are not followed for each drug product.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• Results not used for expiration dates, storage cond. 21 CFR 211.166(a)
  Results of stability testing are not used in determining expiration dates.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• Results not used for expiration dates, storage cond. 21 CFR 211.166(a)
  Results of stability testing are not used in determining expiration dates.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• Results not used for expiration dates, storage cond. 21 CFR 211.166(a)
  Results of stability testing are not used in determining expiration dates.
• Accurate reproduction 21 CFR 211.188(a)
  The batch production and control records are deficient in that they are not an accurate reproduction of the appropriate master production or control record.
• Accurate reproduction 21 CFR 211.188(a)
  The batch production and control records are deficient in that they are not an accurate reproduction of the appropriate master production or control record.
• Accurate reproduction 21 CFR 211.188(a)
  The batch production and control records are deficient in that they are not an accurate reproduction of the appropriate master production or control record.
• Investigations made into any unexplained discrepancy 21 CFR 211.188(b)(12)
  Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.
• Investigations made into any unexplained discrepancy 21 CFR 211.188(b)(12)
  Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.
• Investigations made into any unexplained discrepancy 21 CFR 211.188(b)(12)
  Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing, processing and holding of a drug product are not maintained in a good state of repair.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing, processing and holding of a drug product are not maintained in a good state of repair.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing, processing and holding of a drug product are not maintained in a good state of repair.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, instructions for removal or obliteration of previous batch identification and instructions for protection of clean equipment from contamination prior to use.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, instructions for removal or obliteration of previous batch identification and instructions for protection of clean equipment from contamination prior to use.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, instructions for removal or obliteration of previous batch identification and instructions for protection of clean equipment from contamination prior to use.

Mar 13, 2020 inspection

• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Reason for Not Conducting Complaint Investigation 21 CFR 211.198(b)(3)
  Complaint records are deficient in that they do not document the reason and the individual making the decision not to conduct a complaint investigation.
• Reason for Not Conducting Complaint Investigation 21 CFR 211.198(b)(3)
  Complaint records are deficient in that they do not document the reason and the individual making the decision not to conduct a complaint investigation.
• Reason for Not Conducting Complaint Investigation 21 CFR 211.198(b)(3)
  Complaint records are deficient in that they do not document the reason and the individual making the decision not to conduct a complaint investigation.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
• Objectionable microbiological contamination 21 CFR 211.84(d)(6)
  Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
• Objectionable microbiological contamination 21 CFR 211.84(d)(6)
  Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
• Objectionable microbiological contamination 21 CFR 211.84(d)(6)
  Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.

Dec 3, 2015 inspection

• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not followed.
• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not followed.
• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not followed.
• Lab controls established, including changes 21 CFR 211.160(a)
  The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
• Lab controls established, including changes 21 CFR 211.160(a)
  The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
• Lab controls established, including changes 21 CFR 211.160(a)
  The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of instruments is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limits are not met.
• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of instruments is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limits are not met.
• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of instruments is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limits are not met.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• Second person sign off 21 CFR 211.194(a)(8)
  Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
• Second person sign off 21 CFR 211.194(a)(8)
  Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
• Second person sign off 21 CFR 211.194(a)(8)
  Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
• Quarantine of Rejected Components et. al. 21 CFR 211.89
  Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
• Quarantine of Rejected Components et. al. 21 CFR 211.89
  Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
• Quarantine of Rejected Components et. al. 21 CFR 211.89
  Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.

Registered with FDA for: manufacture.