Drugs

FDA Posts FDA-483s from 2 Indian Companies

FDA has just released the forms FDA-483 issued following an 8/26-9/6 inspection at Granules India Limited in Telangana, India, and a 7/25-8/2 inspection at Gland Pharma Limited Units I&II, also in Telangana. Both companies are listed as manufacturing human drugs.

The Granules document lists these inspection observations:

failure to clean equipment and utensils at appropriate intervals to prevent conditions that would alter the safety, identity, strength, quality, or purity of the drug product;
failure to thoroughly review any unexplained discrepancy and the failure of a batch, or any of its components, to meet any of its specifications, whether or not the batch has already been distributed;
failure to maintain in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
failure to adequately assess a redacted process to ensure that material obtained from the process is of suitable quality before further processing;
failure to follow written procedures that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch; and
failure to maintain buildings and facilities to ensure that products manufactured meet the quality, purity characteristics, identity, and strength that they purport.

The Gland Pharma form FDA-483 has these observations:

failure to establish in writing and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions; and
failure to maintain in writing and fully follow the responsibilities and procedures applicable to the quality control unit.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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