Drug factory · FDA FEI 2523348

Frontida BioPharm, LLC

7722 Dungan Road, Philadelphia, PA, 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 19, 2019 inspection

• 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.

Mar 31, 2017 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.

Jul 17, 2015 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Distribution Recall System 21 CFR 211.150(b)
  The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.
• Distribution Recall System 21 CFR 211.150(b)
  The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established standards, specifications, and quality control criteria are not rejected.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established standards, specifications, and quality control criteria are not rejected.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• 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.
• Sample identification and other information 21 CFR 211.194(a)(1)
  Laboratory records do not include a description of the sample received for testing, the source or location from where the sample was obtained, the quantity of the sample, the date the sample was taken, and the date the sample was received for testing.
• Sample identification and other information 21 CFR 211.194(a)(1)
  Laboratory records do not include a description of the sample received for testing, the source or location from where the sample was obtained, the quantity of the sample, the date the sample was taken, and the date the sample was received for testing.
• 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.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Mix-up 21 CFR 314.81(b)(1)(i)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be applied to another article.
• Mix-up 21 CFR 314.81(b)(1)(i)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be applied to another article.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.

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