FDA Inspection 656974 — Lincare Inc
The FDA completed an inspection of Lincare Inc on Apr 12, 2010 in Rolla, 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 12, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rolla, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4386 | 21 CFR 211.198(b) | Written complaint record to be maintained at facility |
| 4576 | 21 CFR 211.192 | No written record of investigation |