Drug factory · FDA FEI 3007373532

Aurobindo Pharma Limited

Unit-VII, Sy No. 411/P, 425/P, 434/P, 435/P & 458/P, Plot S1 Part SEZ, TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar, 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.

May 10, 2022 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.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• 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.
• 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.
• 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.

Registered with FDA for: analysis; manufacture.