Drug factory · FDA FEI 3012977526
Zydus Lifesciences Limited
Plot Survey No. 23, 25/P, 37, 40/P, 42 to 47, Sarkhej-Bavla N.H. No. 8A, Opp. Ramdev Masala, Village-Changodar, Tal:Sanand, Dist-Ahmedabad, Ahmedabad, India
Problems found, fixed voluntarily at FDA's last inspection, May 5, 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: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fulvestrant | Makes it and tests it | Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. | 70771-1626, 70710-1688 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 5, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
| Jun 13, 2023 | 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.
May 5, 2026 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - In-process materials characteristics testing 21 CFR 211.110(c)
In-process materials are not tested for quality and approved or rejected by the quality control unit during the production process. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Floors, walls, ceiling surfaces 21 CFR 211.42(c)(10)(i)
Aseptic processing areas are deficient in that floors and walls are not smooth and/or hard surfaces that are easily cleanable. - 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; manufacture.