FDA Inspection 1157187 — Accra-Pac, Inc.
The FDA completed an inspection of Accra-Pac, Inc. on Nov 5, 2021 in Elkhart, IN. 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 5, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Elkhart, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |