Drug factory · FDA FEI 3012112224
Acme Generics Private Limited
Plot No. 115, HPSIDC Industrial Area Davni, P.O. Gurumajra, Tehsil Nalagarh, Solan, India
Problems found, fixed voluntarily at FDA's last inspection, Feb 20, 2026.
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 2026: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carvedilol | Makes it, tests it, packages it and labels it | Advagen Pharma Ltd. | 72888-034, 72888-035, 72888-036 +1 |
| Mycophenolic Acid | Makes it | Biocon Pharma Inc., airis PHARMA Private Limited | 70377-126, 70377-127, 71151-030 +1 |
| Tadalafil | Makes it and tests it | Accord Healthcare Inc. | 16729-369, 16729-370, 16729-371 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 20, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 20, 2026 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Registered with FDA for: analysis; label; manufacture; pack.