FDA Inspection 1120766 — Winder Laboratories, LLC
The FDA completed an inspection of Winder Laboratories, LLC on Mar 13, 2020 in Winder, GA. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 13, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Winder, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1849 | 21 CFR 211.84(d)(6) | Objectionable microbiological contamination |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2621 | 21 CFR 211.198(b)(3) | Reason for Not Conducting Complaint Investigation |