Drug factory · FDA FEI 3005587313

Mylan Laboratories Limited

(FDF-1), F-4 and F-12, Malegaon MIDC, Sinnar, Nasik District, Nashik, India

Serious problems, FDA action at FDA's last inspection, May 15, 2026.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

9 drug inspections on record since 2009: 4 with no problems, 3 with problems fixed voluntarily, 2 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Paliperidone	Makes it	Archis Pharma LLC	72819-158, 72819-159, 72819-160

Ended	Result	Program	Problems noted
May 15, 2026	Serious problems, FDA action	Drug Quality Assurance	—
Feb 7, 2020	No problems found	Drug Quality Assurance	—
Jan 18, 2019	No problems found	Drug Quality Assurance	—
Apr 12, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 14, 2016	Serious problems, FDA action	Drug Quality Assurance	6
Mar 25, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Aug 30, 2012	No problems found	Drug Quality Assurance	—
May 27, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—
Aug 8, 2009	No problems found	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Records - production, process control: electronic 21 CFR 111.95(a)
Your electronic records for your production and process control system do not comply with the electronic records requirements.
Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Investigations of discrepancies, failures 21 CFR 211.192
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.
Written record of complaint to include findings, follow-up 21 CFR 211.198(b)(2)
Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
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.
Computer control of master formula records 21 CFR 211.68(b)
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.

Registered with FDA for: analysis; label; manufacture; pack.