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FDA establishment 3014319211, Puducherry, India. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 2
Official action indicated: 1
Last inspection ended: Aug 12, 2026
Warning letters: 0
Import refusals since 2024: 1
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 211.80(a). Written Procedures Not Followed Written procedures are not followed for the testing of components.
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 211.100(b). SOPs not followed / documented Written production and process control procedures are not documented at the time of performance.
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 components and drug products conform to appropriate standards of identity, strength, quality and purity.
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 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
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 211.67(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 211.100(a). Absence of Written Procedures Your firm failed to establish adequate 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 211.84(d)(1). Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.194(a). Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
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.
Official Action Indicated (OAI)
Nov 25, 2022
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Import Refusals
1 refused shipment lines since 2024, grouped by product and charges
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
Puducherry, India. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.