FDA Inspection 661346 — Chesapeake Surgical, Ltd.
The FDA completed an inspection of Chesapeake Surgical, Ltd. on May 11, 2010 in Laurel, MD. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 11, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Laurel, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12334 | 21 CFR 1271.170(c) | Trained or re-trained as necessary |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |
| 15024 | 21 CFR 1271.320(b) | Available for review and copying by FDA |