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.
FDA establishment 3007549629, Pithampur, India. Part of Lupin's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 6
Official action indicated: 4
Last inspection ended: Jul 17, 2025
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 2 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 211.192. 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 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
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 211.110(a). Written in-process control procedures Written procedures are not established and followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch.
Official Action Indicated (OAI)
Jan 25, 2019
Drugs · Drug Quality Assurance
6 cited references
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 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
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 211.160(a). Following/documenting laboratory controls Established laboratory control mechanisms are not documented at the time of performance.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
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)
May 19, 2017
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Jan 23, 2015
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Jun 22, 2012
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Nov 18, 2009
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
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
Pithampur, India. Part of