Drug factory · FDA FEI 1819171

Lannett Company, LLC

1101 C Ave W, Seymour, IN, 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.

Feb 2, 2018 inspection

• Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
  The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in packing.
• 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.

Oct 31, 2012 inspection

• Acceptance criteria for sampling & testing 21 CFR 211.165(d)
  Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy 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.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or 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.
• 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.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

May 13, 2011 inspection

• Identification of containers, lines, equipment 21 CFR 211.105(a)
  All processing lines used during the production of a batch of drug product is not properly identified at all times to indicate contents.
• 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.

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