Drug factory · FDA FEI 3018011011

Macleods Pharmaceuticals Limited

Plot No M-50 to M-54-A Indore, Special Economic Zone, Phase II, Pithampur., Dhar, India

Problems found, fixed voluntarily at FDA's last inspection, Aug 23, 2024.

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

1 drug inspection on record since 2024: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Amlodipine and Valsartan	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited	33342-279, 33342-280, 33342-281 +1
Bupropion	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited	33342-526, 33342-527, 33342-528
Candesartan	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited, Northstar Rx LLC.	33342-114, 33342-115, 33342-116 +3
Dapagliflozin	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited	33342-585, 33342-586
Dapsone	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited	33342-534, 33342-535
Irbesartan	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited, Northstar Rx LLC.	33342-047, 33342-048, 33342-049 +3
Labetalol	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited	33342-515, 33342-516, 33342-517
Mexiletine	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited	33342-555, 33342-556, 33342-557
Nintedanib	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited	33342-550, 33342-551
Sacubitrilat and Valsartan	Makes it, tests it, packages it and labels it	Northstar Rx LLC.	72603-880, 72603-881, 72603-882
Tenofovir	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited	33342-096
Ticagrelor	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited, Northstar Rx LLC.	33342-431, 33342-432, 72603-940 +1
Tofacitinib	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited	33342-541, 33342-542
Valsartan	Makes it, tests it, packages it and labels it	Macleods Pharmaceuticals Limited	33342-062, 33342-063, 33342-064 +1

FDA inspection history

Ended	Result	Program	Problems noted
Aug 23, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	3

What inspectors wrote down

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

Aug 23, 2024 inspection

Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
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.

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