FDA Inspection
Epic Pharma, LLCEpic Pharma, LLC – FDA Inspection, Jun 12, 2026
Record Details
This FDA Inspection record concerns Epic Pharma, LLC, with an inspection on June 12, 2026, issued by the New York District Office, covering human drugs.
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ID · c05124de-665f-4a2d-a6df-5d2cd61ffa71
Inspection Facts
- Inspection number
- 1304516
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 314.81(b)(1)(i)Mix-up
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Other FDA inspections of Epic Pharma, LLC
12| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| April 21, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Epic Pharma, LLC
- FDA Inspection 1227191 - 2023-12-07
- FDA Inspection 1221675 - 2023-10-23
- FDA Inspection 1077818 - 2019-02-01
- FDA Inspection 1070991 - 2018-11-06
- FDA Inspection 1009094 - 2017-04-21
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