FDA Inspection 774479 — Health Park Medical Center
The FDA completed an inspection of Health Park Medical Center on Mar 29, 2012 in Fort Myers, FL. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 29, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Myers, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 117 | 21 CFR 606.121(f) | Labeling of blood products unsuitable for transfusion |
| 49 | 21 CFR 606.40(a)(9) | Provide space for all packaging, labeling, & finishing ops. |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9077 | 21 CFR 600.12(a) | Maintenance - completeness |