FDA Inspection 1182373 — Greer Laboratories, Inc.
The FDA completed an inspection of Greer Laboratories, Inc. on Nov 1, 2022 in Lenoir, NC. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 1, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lenoir, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |