Drug factory · FDA FEI 3005757050
Glenmark Pharmaceuticals Limited
Village Kishanpura Baddi Nalagarh Road, Baddi, Solan, India
Serious problems, FDA action at FDA's last inspection, Jun 22, 2022.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
6 drug inspections on record since 2009: 2 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Alclometasone | Makes it and tests it | Glenmark Pharmaceuticals Inc., USA | 68462-299, 68462-300 |
| Atovaquone | Makes it and tests it | Glenmark Pharmaceuticals Inc., USA | 68462-421 |
| Clobetasol | Makes it and tests it | Northstar Rx LLC. | 16714-782 |
| Nystatin and Triamcinolone Acetonide | Makes it and tests it | Glenmark Pharmaceuticals Inc., USA | 68462-799 |
| Triamcinolone Acetonide | Makes it and tests it | Glenmark Pharmaceuticals Inc., USA | 68462-131, 68462-797, 68462-798 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 22, 2022 | Serious problems, FDA action | Drug Quality Assurance | 6 |
| Sep 21, 2018 | No problems found | Drug Quality Assurance | — |
| Nov 11, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
| May 29, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 24, 2012 | No problems found | Drug Quality Assurance | — |
| Nov 13, 2009 | Problems found, fixed voluntarily | 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.
Jun 22, 2022 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no 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. - 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. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - input/output verification 21 CFR 211.68(b)
Input to and output from the computer and records or data are not checked for accuracy. - Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
Nov 11, 2017 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no 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. - Records reviewed annually 21 CFR 211.180(e)
Records are not maintained 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. - 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. - Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
Complaint records are deficient in that they do not include the findings of the investigation and follow-up. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function. - 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.
Registered with FDA for: analysis; label; manufacture; pack.