Drug factory · FDA FEI 3008565058
Glenmark Pharmaceuticals Limited
Plot No. 2, Phase-2, Pharma Zone SEZ Pithampur, Dhar, India
Serious problems, FDA action at FDA's last inspection, Feb 14, 2025.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
8 drug inspections on record since 2013: 4 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 14, 2025 | Serious problems, FDA action | Drug Quality Assurance | 5 |
| Feb 25, 2020 | No problems found | Drug Quality Assurance | — |
| Sep 13, 2019 | No problems found | Drug Quality Assurance | — |
| May 24, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 26, 2017 | No problems found | Drug Quality Assurance | — |
| Feb 26, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jul 24, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 25, 2013 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 14, 2025 inspection
- Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented. - Investigations of discrepancies, failures 21 CFR 211.192
There is a 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 been already distributed. - Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the quality of drug products. - Mfg / Processing Operations Area 21 CFR 211.42(c)(5)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
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.
Feb 26, 2016 inspection
- Control procedures fail to include the following 21 CFR 211.110(a)
Control procedures fail to include tablet or capsule weight variation and adequacy of mixing to assure uniformity and homogeneity. - Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not established. Electronic records are used, but they do not meet systems validation, operational system check, employee accountability/responsibility policy, and systems documentation control requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Electronic records are used, but they do not meet systems validation, system access limitation, audit trail, operational system check, employee accountability/responsibility policy, systems documentation control, and open systems control requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Registered with FDA for: analysis; label; manufacture; pack.