FDA Inspection 874818 — US Compounding Inc
The FDA completed an inspection of US Compounding Inc on Mar 27, 2014 in Conway, AR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 27, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Conway, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |