Arca
Skip to content
Tools
Tools

Zydus Lifesciences Limited

FDA establishment 3012977526, Ahmedabad, India. Part of Zydus Lifesciences's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.

  • Inspections: 2
  • Official action indicated: 0
  • Last inspection ended: May 5, 2026
  • Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

Most Cited at This Site

Inspections citing each reference

Inspections

2 inspections, newest first
EndedProduct and areaCitationsClassification
May 5, 2026Drugs · Drug Quality Assurance
7 cited references
  • 21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process.
  • 21 CFR 211.100(a). Absence of Written Procedures 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.
  • 21 CFR 211.42(c)(10)(i). Floors, walls, ceiling surfaces Aseptic processing areas are deficient in that floors and walls are not smooth and/or hard surfaces that are easily cleanable.
  • 21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
  • 21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
  • 21 CFR 211.110(c). In-process materials characteristics testing In-process materials are not tested for quality and approved or rejected by the quality control unit during the production process.
  • 21 CFR 211.68(b). Computer control of master formula records 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.
Voluntary Action Indicated (VAI)
Jun 13, 2023Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)

Identifiers

FEI number
3012977526
FDA firm profile
Data Dashboard

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.