FDA Inspection
Stokes Healthcare Inc. dba Epicur PharmaStokes Healthcare Inc. dba Epicur Pharma – FDA Inspection, May 23, 2025
Record Details
This FDA Inspection record concerns Stokes Healthcare Inc. dba Epicur Pharma, with an inspection on May 23, 2025, issued by the New Jersey District Office, covering human drugs.
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ID · 40686dde-4322-4667-9417-802ba53f178c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1267068
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.42(c)(10)(v)Cleaning System
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Other FDA inspections of Stokes Healthcare Inc. dba Epicur Pharma
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2023 | OAI | Drug Quality Assurance | |
| June 19, 2018 | Not classified | New Jersey District Office | |
| February 12, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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