FDA Inspection 1048961 — ABC Compounding Co., Inc.
The FDA completed an inspection of ABC Compounding Co., Inc. on April 19, 2018 in Conyers, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 19, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Conyers, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 21297 | 21 CFR 211.186(a) | Master production and control records, procedure |
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |