FDA Inspection 648127 — Lincare
The FDA completed an inspection of Lincare on Feb 24, 2010 in Washington, 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 24, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Washington, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |