Drug factory · FDA FEI 3006370524

Alkem Laboratories Limited

Srv. No. 167, Plot No. 164, 165/1, 165/2, 165/3, 168/215, 168/216, 168/234, Village Dabhel, Amaliya Daman, 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.

Mar 27, 2018 inspection

• Identification of containers, lines, equipment 21 CFR 211.105(a)
  All processing lines and major equipment used during the production of a batch of drug product is not properly identified at all times to indicate the phase of processing of the batch. Electronic signatures based on are used, but they do not meet the requirements of 21 CFR Part 11.
• Tablet or capsule weight variation 21 CFR 211.110(a)(1)
  The in-process control procedures were deficient in that it did not include an examination of tablet and capsule weight variation.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not documented at the time of performance.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that drug products 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.
• Failing to test for penicillin cross-contamination 21 CFR 211.176
  Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed that a non-penicillin drug product has been exposed to a cross-contamination with penicillin.
• 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. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
• Approve or reject components, products 21 CFR 211.22(a)
  The quality control unit lacks the responsibility and authority to approve and reject all components, in process materials and drug products.
• Lack of quality control unit 21 CFR 211.22(a)
  There is no quality control unit.
• 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.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.
• 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 and free of infestation by rodents, birds insects, and other vermin.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product.

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