FDA Inspection
Stokes Healthcare Inc. dba Epicur PharmaStokes Healthcare Inc. dba Epicur Pharma – FDA Inspection, Oct 25, 2023
Record Details
This FDA Inspection record concerns Stokes Healthcare Inc. dba Epicur Pharma, with an inspection on October 25, 2023, covering drugs.
- Inspection Date
- October 25, 2023
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ID · afcd9d72-bdac-49b6-af96-7fe09884ec93
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1221039
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 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 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- FDCA 503B(a)(10)(A)Drug product labels, fails to include
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Other FDA inspections of Stokes Healthcare Inc. dba Epicur Pharma
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2025 | OAI | New Jersey District Office | 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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