FDA Inspection 947800 — Health Network Laboratories-Pocono
The FDA completed an inspection of Health Network Laboratories-Pocono on November 10, 2015 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 10, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- East Stroudsburg, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 165 | 21 CFR 606.170(a) | Adverse reaction - Maintenance of Reports |
| 88 | 21 CFR 606.100(b)(9) | Written methods for investigating adverse reactions |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |