FDA Inspection 731370 — Arch Medical Solutions - Escondido LLC
The FDA completed an inspection of Arch Medical Solutions - Escondido LLC on June 22, 2011 in Escondido, 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
- June 22, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Escondido, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3264 | 21 CFR 820.250(b) | Sampling methods - Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |