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FDA establishment 3002984011, Ahmedabad, India. Part of Zydus Lifesciences's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 10
Official action indicated: 3
Last inspection ended: Aug 5, 2022
Warning letters: 2
Import refusals since 2024: 2
Import refusals 2014 to 2023: 8, first Aug 13, 2014
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.111. Establishment of time limitations Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
21 CFR 211.80(a). Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the identification, handling and sampling of components and drug product containers.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Voluntary Action Indicated (VAI)
May 3, 2019
Drugs · Drug Quality Assurance
14 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 aseptic process.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
21 CFR 211.186(b)(9). Complete instructions, procedures, specifications et. al. Master production and control records lack complete manufacturing and control instructions.
21 CFR 211.42(c)(10)(iii). Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
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 and followed.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance 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.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.68(b). Backup file not maintained Failure to maintain a backup file of data entered into the computer or related system.
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(b). In-process materials specifications In-process specifications are not determined by the application of suitable statistical procedures where appropriate.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.46(c). Air filtration system lacking in production area The production area air supply lacks an appropriate air filtration system.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Official Action Indicated (OAI)
Mar 22, 2019
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
Feb 9, 2018
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Feb 16, 2017
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Sep 5, 2014
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.192. Extent of discrepancy, failure investigations Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
21 CFR 211.198(b)(2). Written record of complaint to include findings, follow-up Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.
21 CFR 314.81(b)(1)(i). Mix-up An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be mistaken for another article.
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Official Action Indicated (OAI)
Aug 19, 2013
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Feb 23, 2012
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Feb 3, 2011
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Feb 6, 2009
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Warning Letters
Letters naming this establishment; each opens the letter
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Ahmedabad, India. Part of