Drug factory · FDA FEI 3005903939
Amneal Oncology Private Limited
Plot No. S-3, S-4, S-5A, TSIIC-SEZ Village-Polepally Mandal-Jadcherla MAHABOOBNAGAR, Mahaboobnagar, India
Problems found, fixed voluntarily at FDA's last inspection, Oct 25, 2019.
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 2018: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bortezomib | Makes it, tests it, packages it, labels it and sterilizes it | Amneal Pharmaceuticals LLC, Shilpa Medicare Limited | 70121-2484, 63759-3032 |
| Nelarabine | Makes it, tests it, packages it, labels it and sterilizes it | Amneal Pharmaceuticals LLC | 70121-1743 |
| Plerixafor | Makes it, tests it, packages it, labels it and sterilizes it | Amneal Pharmaceuticals LLC | 70121-1694 |
| Romidepsin | Makes it, tests it, packages it, labels it and sterilizes it | Amneal Pharmaceuticals LLC | 70121-2250 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 25, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 15, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 25, 2019 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.
Mar 15, 2018 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not recorded and justified. - 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. - Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.