Drug factory · FDA FEI 3007027193
Par Formulations Private Limited
9/215, Pudupakkam-Vandalur Main Road, Pudupakkam, Kelambakkam, , , Chennai, India
Problems found, fixed voluntarily at FDA's last inspection, Jun 10, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2011: 5 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Allopurinol | Makes it, tests it and packages it | ENDO USA, Inc. | 0603-2115, 0603-2116 |
| Dantrolene | Makes it, tests it and packages it | Par Health USA, LLC | 42023-124, 42023-125, 42023-126 +3 |
| Gabapentin | Makes it | Allied Pharma Inc | 76267-150, 76267-151 |
| Methylprednisolone | Makes it, tests it and packages it | Par Health USA, LLC | 0603-4593 |
| Perphenazine | Makes it, tests it and packages it | Par Health USA, LLC | 0603-5060, 0603-5061, 0603-5062 +1 |
| Prednisone | Makes it, tests it and packages it | Par Health USA, LLC | 0603-5335, 0603-5336, 0603-5337 +2 |
| Sapropterin | Makes it, tests it and packages it | ENDO USA, Inc. | 49884-720 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 10, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 24, 2023 | No problems found | Drug Quality Assurance | — |
| Jun 21, 2019 | No problems found | Drug Quality Assurance | — |
| Dec 7, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 17, 2015 | No problems found | Drug Quality Assurance | — |
| Oct 17, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 21, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture; pack.