FDA Inspection 825586 — Adams Meditech LLC
The FDA completed an inspection of Adams Meditech LLC on Apr 2, 2013 in City of Industry, CA. 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
- Apr 2, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- City of Industry, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |