FDA Inspection 1100290 — East Marietta Drug Company
The FDA completed an inspection of East Marietta Drug Company on August 23, 2019 in Marietta, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18939 | FDCA 501(a)(2)(A) | Highly potent drugs, prevention of cross-contamination |
| 18942 | FDCA 501(a)(2)(A) | Personnel habits, contamination |