FDA Inspection 1085801 — Anderson Compounding Pharmacy, Inc.
The FDA completed an inspection of Anderson Compounding Pharmacy, Inc. on Apr 5, 2019 in Bristol, TN. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 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 |