Drug factory · FDA FEI 3005719315
Watson Pharma Private Limited
Plot No. A3-A-6, Phase 1A Verna Industrial Estate, Verna, Salcette, India
Problems found, fixed voluntarily at FDA's last inspection, Jan 23, 2020.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2011: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydrochlorothiazide | Makes it | Actavis Pharma, Inc. | 0591-0347 |
| Hydrochlorothiazide and Triamterene | Makes it | BluePoint Laboratories. | 68001-387, 68001-388 |
| Nortriptyline | Makes it, tests it, packages it and labels it | Mayne Pharma Inc. | 51862-015, 51862-016, 51862-017 +1 |
| Ursodiol | Makes it | Actavis Pharma, Inc. | 0591-3159 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 23, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Apr 26, 2018 | No problems found | Drug Quality Assurance | — |
| Jul 21, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 14, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 8, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 2, 2011 | 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.
Jan 23, 2020 inspection
- Reserve samples identified, representative, stored 21 CFR 211.170(b)
Reserve drug product samples are not appropriately identified. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - 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.
Registered with FDA for: analysis; label; manufacture; pack.