FDA Inspection
Epic Pharma, LLCEpic Pharma, LLC – FDA Inspection, Apr 21, 2017
Record Details
This FDA Inspection record concerns Epic Pharma, LLC, with an inspection on April 21, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fb2b9439-4199-4b4b-8d65-5bb9230cba6e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009094
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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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 |
| November 6, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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 1070991 - 2018-11-06
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