Drug factory · FDA FEI 3007621329
Zydus Lifesciences Limited
Plot No. 1A, PHARMEZ Special Economic Zone, Sarkhej - Bavla N. H. No. 8A, Matoda, Tal : Sanand, Ahmedabad, India
Problems found, fixed voluntarily at FDA's last inspection, Jun 17, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2012: 3 with no problems, 5 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 17, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 27, 2024 | Serious problems, FDA action | Drug Quality Assurance | 4 |
| Feb 4, 2020 | No problems found | Drug Quality Assurance | — |
| Mar 26, 2019 | No problems found | Drug Quality Assurance | — |
| Mar 21, 2019 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Jun 5, 2018 | No problems found | Drug Quality Assurance | — |
| Apr 17, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 31, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 4, 2012 | 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.
Mar 27, 2024 inspection
- 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 written and followed. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair. - 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.
Registered with FDA for: analysis; manufacture.