Drug factory · FDA FEI 3015218020
Aet Laboratories Private Limited
Survey No.42, Gaddapotharam Village, Kazipally Industrial Area, Sangareddy, India
Problems found, fixed voluntarily at FDA's last inspection, Feb 7, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Posaconazole | Makes it | Lupin Pharmaceuticals, Inc. | 70748-258 |
| Sacubitrilat and Valsartan | Makes it and packages it | Lupin Pharmaceuticals, Inc. | 70748-195, 70748-196, 70748-197 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 7, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 20, 2019 | 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.
Feb 7, 2025 inspection
- Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; label; manufacture; pack.