FDA Inspection 1191042 — WHPM Inc.
The FDA completed an inspection of WHPM Inc. on Nov 18, 2022 in Irwindale, 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 18, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Irwindale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |