FDA Inspection 1102216 — Greer Laboratories, Inc.
The FDA completed an inspection of Greer Laboratories, Inc. on Sep 11, 2019 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 11, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Lenoir, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 15973 | 21 CFR 111.120(c) | Quality control operations - material review, disposition decision |
| 3594 | 21 CFR 211.110(d) | Rejected in-process materials not quarantined |
| 6011 | 21 CFR 123.8(a)(3)(ii) | Corrective action record review adequacy |