> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Glenmark Pharmaceuticals FDA-483 Released
- URL: https://www.fdaweb.com/glenmark-pharmaceuticals-fda-483-released/
- Published: 2017-12-06T12:00:00.000Z
- Updated: 2026-09-14T23:06:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140276

FDA has released the FDA-483 issued following an 11/6-11/11 inspection at Glenmark Pharmaceuticals, a finished dosage manufacturer in Solan, Himachal Pradesh, India. Inspection observations were: 

- failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether the batch has already been distributed;
- · failing to have written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- · failing to include in complaint records investigation findings and follow-up;
- · failing to maintain records so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures;
- failing to fully follow responsibilities and procedures applicable to the quality control unit;
- failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel; and
- failing to give employees training in the particular operations they perform as part of their function.