FDA Inspection 1256993 — Greer Laboratories, Inc.
The FDA completed an inspection of Greer Laboratories, Inc. on Dec 18, 2024 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 18, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Lenoir, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |