Drug factory · FDA FEI 3005210225

Micro Labs Limited

Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate, Verna, India

Problems found, fixed voluntarily at FDA's last inspection, May 30, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2009: 2 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Acetazolamide	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-243
Amlodipine and Hydrochlorothiazide and Olmesartan	Makes it	Micro Labs Limited	42571-245, 42571-246, 42571-247 +2
Amlodipine and Olmesartan	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-235, 42571-236, 42571-237 +1
Aspirin and Dipyridamole	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-274
Bisoprolol	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-470, 42571-471
Bupropion	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-241, 42571-242
Celecoxib	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-142, 42571-143, 42571-144 +1
Chlordiazepoxide and Clidinium	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-381
Cholestyramine	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-508
Clindamycin	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-250, 42571-251, 42571-252
Clobazam	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-315, 42571-316
Clomipramine	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-342, 42571-343, 42571-344
Colchicine	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-341
Dalfampridine	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-275
Dapagliflozin	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-317, 42571-318
Dapagliflozin and Metformin	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-320, 42571-321, 42571-322 +1
Diclofenac and Misoprostol	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-133, 42571-134
Famotidine	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-433
Ganciclovir	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-477
Glimepiride	Makes it	BluePoint Laboratories., Lifsa Drugs LLC, Micro Labs Limited	68001-584, 68001-585, 68001-586 +7
Hydrochlorothiazide and Olmesartan	Makes it	Micro Labs Limited	42571-204, 42571-205, 42571-206
Levocetirizine	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-122
Mefenamic Acid	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-258
Metformin	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-333, 42571-334
Methazolamide	Makes it	Bausch & Lomb Incorporated, Micro Labs Limited	24208-022, 24208-023, 42571-239 +1
Methenamine	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-332
Nevirapine	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-131
Nitrofurantoin	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-393
Pirfenidone	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-335, 42571-336
Piroxicam	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-176, 42571-177
Ramelteon	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-375
Rasagiline	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-220, 42571-221
Rivaroxaban	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-345
Roflumilast	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-259, 42571-369
Rufinamide	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-391, 42571-392
Sapropterin	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-509, 42571-510
Ticagrelor	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-263, 42571-293
Tofacitinib	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-268, 42571-377
Varenicline	Makes it, tests it, packages it and labels it	Micro Labs Limited	42571-459, 42571-460, 42571-475

FDA inspection history

Ended	Result	Program	Problems noted
May 30, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	2
Feb 15, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 14, 2017	No problems found	Drug Quality Assurance	—
May 13, 2014	Serious problems, FDA action	Drug Quality Assurance	—
Nov 17, 2011	No problems found	Drug Quality Assurance	—
Apr 17, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—

What inspectors wrote down

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

May 30, 2025 inspection

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigations of discrepancies, failures 21 CFR 211.192
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.

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