FDA Inspection 971941 — A. R. Hinkel Company, Inc.
The FDA completed an inspection of A. R. Hinkel Company, Inc. on Jun 6, 2016 in Simi Valley, 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 6, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Simi Valley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |