Drug factory · FDA FEI 1210580

Denison Pharmaceuticals, LLC

One Powder Hill Road, Lincoln, RI, 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.

Jul 29, 2024 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish adequate 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.
• Component addition checked by 2nd person 21 CFR 211.101(d)
  Each component is not added to a batch by one person and verified by a second person.
• Label storage access limited to authorized personnel 21 CFR 211.122(d)
  Access to the storage area for labels and labeling materials is not limited to authorized personnel.
• Strict control not exercised over labeling issued 21 CFR 211.125(a)
  Strict control is not exercised over labeling issued for use in drug product labeling operations.
• Written records kept in individual logs 21 CFR 211.182
  Written records of major equipment cleaning are not included in individual equipment logs.
• 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.
• Quality control unit review of records 21 CFR 211.192
  Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or 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.
• Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
  Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
• Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
  Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Feb 9, 2023 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish adequate 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.
• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
• 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.
• 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.
• Habits of good sanitation & health 21 CFR 211.28(b)
  Production personnel were not practicing good sanitation and health habits.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Component identity verification 21 CFR 211.84(d)(1)
  Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
• Protection from external factors 21 CFR 211.94(b)
  Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.

Apr 5, 2016 inspection

• Lab controls established, including changes 21 CFR 211.160(a)
  The establishment of specifications , standards , sampling plans , test procedures and 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 specifications , standards , sampling plans , test procedures and 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 specifications , standards , sampling plans , test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
• Test methods 21 CFR 211.165(e)
  The accuracy , sensitivity , specificity and reproducibility of test methods have not been established and documented.
• Test methods 21 CFR 211.165(e)
  The accuracy , sensitivity , specificity and reproducibility of test methods have not been established and documented.
• Test methods 21 CFR 211.165(e)
  The accuracy , sensitivity , specificity and reproducibility of test methods have not been established and documented.
• 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.
• Data secured in course of each test 21 CFR 211.194(a)(4)
  Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs , charts and spectra from laboratory instrumentation, properly identified to show the specific component , drug product container , in-process material , lot tested and drug product tested.
• Data secured in course of each test 21 CFR 211.194(a)(4)
  Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs , charts and spectra from laboratory instrumentation, properly identified to show the specific component , drug product container , in-process material , lot tested and drug product tested.
• Data secured in course of each test 21 CFR 211.194(a)(4)
  Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs , charts and spectra from laboratory instrumentation, properly identified to show the specific component , drug product container , in-process material , lot tested and drug product tested.
• 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 to assure that employees remain familiar with CGMP requirements applicable to them.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing , processing , packing 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 , packing 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 , packing and holding of a drug product are not maintained in a good state of repair.
• Computer control of master formula records 21 CFR 211.68(b)
  Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
• Computer control of master formula records 21 CFR 211.68(b)
  Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
• Computer control of master formula records 21 CFR 211.68(b)
  Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Aug 5, 2009 inspection

• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not 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.
• 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.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the holding of a drug product are not maintained in a good state of repair.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: analysis; label; manufacture; pack.