FDA Inspection
Epic Pharma, LLCEpic Pharma, LLC – FDA Inspection, Nov 6, 2018
Record Details
This FDA Inspection record concerns Epic Pharma, LLC, with an inspection on November 6, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Iram R. Hassan (Company Rep)
- Joy P. Matthias (Issuing Officer)
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ID · b00e0089-10e4-4d2e-8f55-1b532dd48ae3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070991
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Epic Pharma, LLC
12| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2026 | Not classified | New York District Office | Drug Quality Assurance |
| December 7, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 23, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 1, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 21, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Epic Pharma, LLC
- FDA Inspection 1304516 - 2026-06-12
- FDA Inspection 1227191 - 2023-12-07
- FDA Inspection 1221675 - 2023-10-23
- FDA Inspection 1077818 - 2019-02-01
- FDA Inspection 1009094 - 2017-04-21
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