Drug factory · FDA FEI 3004021229

Aurobindo Pharma Limited

Unit-III, Sy. No.313 & 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District, Medchal, 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.

Jul 21, 2023 inspection

• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not followed.
• 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.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

May 24, 2019 inspection

• Storage conditions 21 CFR 211.137(b)
  Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies.
• Active ingredient retained sample kept 21 CFR 211.170(a)
  A sample which is representative of each lot in each shipment of each active ingredient is not appropriately identified and retained.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• Written record of complaint to include findings, follow-up 21 CFR 211.198(b)(2)
  Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.
• 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.
• Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
  Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
• 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.
• 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.

Aug 10, 2018 inspection

• Failure to develop written procedures 21 CFR 314.80(b)
  Written procedures have not been developed for the surveillance, receipt and evaluation of post marketing adverse drug experiences.
• Incomplete periodic safety report 21 CFR 314.80(c)(2)(ii)(A)
  You failed to submit a periodic report containing a narrative summary and analysis of the ADE information for the reporting interval in the report.

Apr 18, 2017 inspection

• Deviations from laboratory control requirements 21 CFR 211.160(a)
  Deviations from written test procedures are not recorded and justified.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
• Test methods 21 CFR 211.165(e)
  The sensitivity of test methods have not been.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• 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.
• 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.

Registered with FDA for: analysis; manufacture.