FDA Inspection 787702 — The Anspach Effort, Inc.
The FDA completed an inspection of The Anspach Effort, Inc. on May 22, 2012 in Palm Beach Gardens, FL. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 22, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Palm Beach Gardens, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4211 | 21 CFR 806.20(b)(3) | Events |
| 537 | 21 CFR 820.70(a) | Production processes |