FDA Inspection 1044809 — Phillips-Medisize Costa Mesa, LLC
The FDA completed an inspection of Phillips-Medisize Costa Mesa, LLC on March 15, 2018 in Costa Mesa, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 15, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Costa Mesa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |