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FDA establishment 3005587313, Nashik, India. Part of Mylan Laboratories'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: 9
Official action indicated: 2
Last inspection ended: May 15, 2026
Warning letters: 1
Import refusals since 2024: 1
Import refusals 2014 to 2023: 8, first Jul 12, 2016
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 211.198(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 111.95(a). Records - production, process control: electronic Your electronic records for your production and process control system do not comply with the electronic records requirements.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review 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 211.165(e). Test methods The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
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.
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.
Official Action Indicated (OAI)
Mar 25, 2015
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Aug 30, 2012
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
May 27, 2011
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Aug 8, 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
Nashik, India. Part of