Drugs

13 Observations in Alkem FDA-483

David McFarland

— 2 min read
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FDA has released the FDA-483 with 13 observations issued following a 3/19-3/27 inspection at Alkem Laboratories, a Daman and Diu, India, drug manufacturing plant. The observations were: 

  •          there is no quality control unit;
  •          the quality control unit lacks the responsibility and authority to approve and reject all components, in process materials and drug products;
  •          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;
  • ·        the responsibilities and procedures applicable to the quality control unit are not fully followed;
  •          the written stability testing program is not followed;
  •          laboratory records do not include complete data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards, and electronic records that are used do not meet requirements to ensure that they are trustworthy, reliable, and generally equivalent to paper records;
  •          established laboratory control mechanisms are not documented at the time of performance;
  •          the in-process control procedures are deficient in that it did not include an examination of tablet and capsule weight variation;
  •          all processing lines and major equipment used during the production of a batch product are not properly identified at all times to indicate the phase of processing of the batch;
  •          equipment and utensils are not [cleaned] at appropriate intervals to prevent [contamination] that would alter the safety, identity, strength, quality, or purity of the drug product;
  •          specified drug products are not tested for the presence of a redacted contaminant when a reasonable possibility exists that a drug product has been exposed to cross-contamination;
  •          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; and
  •          employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.

The FDA-483 says that several of the items are repeat observations.

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