FDA Inspection 1267068 — Stokes Healthcare Inc.
The FDA completed an inspection of Stokes Healthcare Inc. on May 23, 2025 in Mount Laurel, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 23, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mount Laurel, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |