Drug factory · FDA FEI 3008460260

Umedica Laboratories Private Limited

Plot No. 221 and 221/1, GIDC, IInd Phase, , Vapi, India

Problems found, fixed voluntarily at FDA's last inspection, Mar 29, 2024.

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

4 drug inspections on record since 2015: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Atorvastatin	Makes it, tests it and packages it	Pharmaceutical Associates, Inc., Umedica Laboratories USA Inc.	75834-255, 75834-256, 75834-257 +5
Carbamazepine	Makes it and tests it	Jubilant Cadista Pharmaceuticals Inc., Northstar Rx LLC., Pharmaceutical Associates, Inc., Umedica Laboratories USA Inc.	59746-789, 59746-790, 59746-791 +10
Celecoxib	Makes it, tests it and packages it	Pharmaceutical Associates, Inc., Umedica Laboratories USA Inc.	75834-236, 75834-237, 75834-238 +5
Chlorthalidone	Makes it, tests it and packages it	Pharmaceutical Associates, Inc., Umedica Laboratories USA Inc.	75834-109, 75834-110, 60290-004 +1
Diclofenac	Makes it, tests it and packages it	Pharmaceutical Associates, Inc., Umedica Laboratories USA Inc., Zydus Pharmaceuticals (USA) Inc.	75834-337, 75834-338, 60290-057 +6
Fluphenazine	Makes it	Zameer Pharmaceuticals LLC	90096-121, 90096-122, 90096-123 +1
Hydrochlorothiazide and Olmesartan	Makes it, tests it and packages it	Lifestar Pharma LLC., Umedica Laboratories USA Inc.	70756-812, 70756-813, 70756-814 +3
Macitentan	Makes it, tests it and packages it	Zydus Pharmaceuticals (USA) Inc.	70710-1166
Olmesartan	Makes it, tests it and packages it	Lifestar Pharma LLC., Umedica Laboratories USA Inc.	70756-808, 70756-809, 70756-810 +3
Oxcarbazepine	Makes it, tests it and packages it	Umedica Laboratories USA Inc., Zameer Pharmaceuticals LLC	60290-067, 60290-068, 60290-069 +3
Ranolazine	Makes it, tests it and packages it	Umedica Laboratories USA Inc.	60290-055, 60290-056
Rosuvastatin	Makes it, tests it and packages it	Northstar Rx LLC., Torrent Pharma, Inc., Umedica Laboratories USA Inc.	72603-364, 72603-365, 72603-366 +9
Sacubitrilat and Valsartan	Makes it, tests it and packages it	Umedica Laboratories USA Inc.	60290-085, 60290-086, 60290-087
Sertraline	Makes it, tests it and packages it	Biocon Pharma Inc., Umedica Laboratories USA Inc.	70377-128, 70377-129, 60290-070 +1
Sildenafil	Makes it, tests it and packages it	Northstar Rx LLC., Pharmaceutical Associates, Inc., Umedica Laboratories USA Inc.	72603-883, 72603-884, 72603-885 +6
Tadalafil	Makes it, tests it and packages it	Northstar Rx LLC., Pharmaceutical Associates, Inc., Umedica Laboratories USA Inc.	72603-781, 72603-782, 72603-783 +9
Varenicline	Makes it, tests it and packages it	Umedica Laboratories USA Inc.	60290-077, 60290-078, 60290-095
Zolpidem	Makes it, tests it and packages it	Torrent Pharma, Inc., Umedica Laboratories USA Inc.	13668-775, 60290-089

FDA inspection history

Ended	Result	Program	Problems noted
Mar 29, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jul 5, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 19, 2018	No problems found	Drug Quality Assurance	—
Oct 9, 2015	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.

Mar 29, 2024 inspection

Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Registered with FDA for: analysis; manufacture; pack.