Drug factory · FDA FEI 2210277

Cosette Pharmaceuticals, Inc.

South Plainfield, New Jersey, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

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.

May 17, 2010 inspection

• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.
• No written record of investigation 21 CFR 211.192
  Written records are not made of investigations into unexplained discrepancies.
• 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 established.
• Approve or reject components, products 21 CFR 211.22(a)
  The quality control unit lacks the responsibility and authority to approve and reject all components, in process materials, and drug products.
• Authority lacking to review records, investigate errors 21 CFR 211.22(a)
  The quality control unit lacks authority to fully investigate errors that have occurred.
• 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 and of adequate size to facilitate operations for its intended use and cleaning and maintenance.
• 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.
• Backup data not assured as exact and complete 21 CFR 211.68(b)
  Backup data is not assured as secure from alteration, erasure or loss through keeping hard copy or alternate systems.

Jun 18, 2009 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Establishment of time limitations 21 CFR 211.111
  Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
• Correct labels during finishing operations 21 CFR 211.134(a)
  Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.
• 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.
• Prepared for each batch, include complete information 21 CFR 211.188
  Batch production and control records do not include complete information relating to the production and control of each batch.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
• 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.
• Authority lacking to review records, investigate errors 21 CFR 211.22(a)
  The quality control unit lacks authority to fully investigate errors that have occurred.
• Approve or reject procedures or specs 21 CFR 211.22(c)
  The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity of drug products.
• 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.
• Protective Apparel Not Worn 21 CFR 211.28(a)
  Protective apparel is not worn as necessary to protect drug products from contamination.
• 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, of adequate size, and suitably located to facilitate operations for its intended use and cleaning and maintenance.
• Backup data not assured as exact and complete 21 CFR 211.68(b)
  Backup data is not assured as exact and secure from alteration, erasure or loss through keeping hard copy or alternate systems.
• input/output verification 21 CFR 211.68(b)
  Input to and output from the computer are not checked for accuracy.
• Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.