FDA Inspection 1020349 — Health Network Laboratories-Pocono
The FDA completed an inspection of Health Network Laboratories-Pocono on August 1, 2017 in East Stroudsburg, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 1, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- East Stroudsburg, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9004 | 21 CFR 606.100(b)(19) | Quarantine of blood etc. |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |