FDA Inspection 760437 — Braemar Manufacturing, LLC
The FDA completed an inspection of Braemar Manufacturing, LLC on December 20, 2011 in San Diego, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 20, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 784 | 21 CFR 803.52(f)(7) | Remedial Action Taken |