Drug factory · FDA FEI 3010960741

Megsan Labs Private Limited

3-31/33, Plot No. 33, Part Sy. No. S - 123, 124, 125 & 142, Kompally, Quthbullapur, Hyderabad, India

Serious problems, FDA action at FDA's last inspection, Aug 22, 2025.

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

4 drug inspections on record since 2016: 0 with no problems, 2 with problems fixed voluntarily, 2 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Alcohol	Tests it	Breckenridge Pharmaceutical, Inc.	51991-999
Tafenoquine	Tests it	60 Degrees Pharmaceuticals, INC.	71475-257

Ended	Result	Program	Problems noted
Aug 22, 2025	Serious problems, FDA action	Drug Quality Assurance	—
Sep 23, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	3
Nov 1, 2019	Serious problems, FDA action	Drug Quality Assurance	2
Jul 15, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—

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

Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed and documented at the time of performance.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
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.

Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed.
Inadequate number of personnel 21 CFR 211.25(c)
The number of qualified personnel is inadequate to perform the processing of each drug product.

Registered with FDA for: analysis.