Drug factory · FDA FEI 3015685305
Alembic Pharmaceuticals Limited
Formulation Division III, Plot No. 779P/790P, Village - Karakhadi, Taluka - Padra, Vadodara, India
Problems found, fixed voluntarily at FDA's last inspection, Feb 18, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2023: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 18, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 24, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
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 24, 2023 inspection
- Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
Registered with FDA for: manufacture.