FDA Inspection 824342 — Foundation Care LLC
The FDA completed an inspection of Foundation Care LLC on Mar 19, 2013 in Earth City, MO. 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 19, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Earth City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 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 |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1999 | 21 CFR 211.184(a) | Record information required |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |