FDA Inspection 1085801 — Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
The FDA completed an inspection of Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy on April 5, 2019 in Bristol, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 5, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bristol, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 18955 | FDCA 501(a)(2)(A) | Ceiling tiles, cleanroom |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |