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# FDA Posts FDA-483s from 2 Indian Companies
- URL: https://www.fdaweb.com/fda-posts-fda-483s-from-2-indian-companies/
- Published: 2024-09-18T12:00:00.000Z
- Updated: 2026-09-14T14:41:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157801

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](http://www.fda.gov/media/181914/download?ref=fdaweb.com) 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](file:///C:/Users/James/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/8U9K4L3O/fda.gov/media/181913/download) 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.