FDA Inspection 957841 — Stokes Healthcare Inc.
The FDA completed an inspection of Stokes Healthcare Inc. on Feb 12, 2016 in Mount Laurel, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 12, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mount Laurel, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |