FDA Inspection 909130 — American Antibiotics, Inc.
The FDA completed an inspection of American Antibiotics, Inc. on December 19, 2014 in Baltimore, MD. 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
- December 19, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |