FDA Inspection 1027754 — Piedmont LLC
The FDA completed an inspection of Piedmont LLC on Oct 4, 2017 in Gainesville, 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 4, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gainesville, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 2621 | 21 CFR 211.198(b)(3) | Reason for Not Conducting Complaint Investigation |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |