FDA Inspection 719457 — Eastern Cranial Affiliates, LLC
The FDA completed an inspection of Eastern Cranial Affiliates, LLC on April 13, 2011 in Fairfax, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 13, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fairfax, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |