Drug factory · FDA FEI 3009876430
Shilpa Medicare Limited
S-20 to S-26, Pharmaceutical Formulations SEZ; TSIIC, Green Industrial Park, Polepally, Jadcherla, Mahabubnagar, India
Serious problems, FDA action at FDA's last inspection, Feb 25, 2020.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
6 drug inspections on record since 2015: 2 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Azacitidine | Makes it, tests it and packages it | Dr. Reddy's Laboratories Inc., Fresenius Kabi, LLC | 43598-678, 63323-771 |
| Decitabine | Makes it | Lupin Pharmaceuticals, Inc. | 68180-738 |
| Imatinib | Makes it | Ascend Laboratories, LLC | 67877-633, 67877-634 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 25, 2020 | Serious problems, FDA action | Drug Quality Assurance | — |
| Sep 6, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 30, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 28, 2017 | No problems found | Drug Quality Assurance | — |
| Jul 26, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 26, 2015 | 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.
Sep 6, 2019 inspection
- Instruments, apparatus, et. al. not meeting specs 21 CFR 211.160(b)(4)
The use of instruments and apparatus not meeting established specifications was observed. - Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed.
Registered with FDA for: analysis; manufacture; pack.