Drug factory · FDA FEI 3003950641

InvaGen Pharmaceuticals, Inc

7 Oser Ave., Hauppauge, NY, 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.

Dec 6, 2019 inspection

• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not followed that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
• Testing and release for distribution 21 CFR 211.165(a)
  Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
• 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 manufacturing and processing.

May 25, 2018 inspection

• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that conform to appropriate standards of identity, strength, quality and purity.
• 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 whether or not the batch has been already distributed.
• Backup file not maintained 21 CFR 211.68(b)
  Failure to maintain a backup file of data entered into the computer or related system.
• 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 mistaken for another article.
• 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.

May 26, 2015 inspection

• 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.

Mar 8, 2013 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include specific test methods.
• 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.

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