Drug factory · FDA FEI 3004082076
Unichem Laboratories Limited
C-31, 32 & D-10, Industrial Area, Meerut Road, Ghaziabad, India
No problems found at FDA's last inspection, Feb 13, 2024.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2012: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Metronidazole | Makes it, tests it and packages it | BluePoint Laboratories. | 68001-364, 68001-365 |
| Valproic Acid | Makes it, tests it, packages it and labels it | BluePoint Laboratories., Unichem Pharmaceuticals (USA), Inc. | 68001-472, 68001-473, 68001-474 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 13, 2024 | No problems found | Drug Quality Assurance | — |
| Aug 23, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 8, 2019 | No problems found | Drug Quality Assurance | — |
| Apr 20, 2018 | No problems found | Drug Quality Assurance | — |
| Mar 3, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 27, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jun 15, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 3, 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. - 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.
Mar 27, 2015 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures are not followed. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review 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.
Jun 15, 2012 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. - Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented. - Testing in same container - closure system 21 CFR 211.166(a)(4)
The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
Registered with FDA for: analysis; label; manufacture; pack.