Drug factory · FDA FEI 3003585876
Solara Active Pharma Sciences Limited
A-1/B, Sipcot Industrial Complex, Kudikadu Village, Cuddalore, India
No problems found at FDA's last inspection, Aug 4, 2023.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2010: 3 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gabapentin | Makes the active ingredient | Ranbaxy Laboratories Inc. | 63304-627, 63304-628, 63304-629 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 4, 2023 | No problems found | Drug Quality Assurance | — |
| Mar 7, 2020 | Serious problems, FDA action | Drug Quality Assurance | — |
| Apr 21, 2017 | No problems found | Drug Quality Assurance | — |
| Jun 13, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 8, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 16, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.