Drug factory · FDA FEI 3008316085

Pfizer Healthcare India Private Limited

Plot No. 116, 117, 118, 119, 111 (Part) and 123 (Part), Jawaharlal Nehru Pharma City (SEZ), Parawada Mandal, Anakapalli, India

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.

Oct 18, 2022 inspection

• 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.

Sep 21, 2018 inspection

• 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.
• 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.
• 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.

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