FDA Inspection
Health Network Laboratories-PoconoHealth Network Laboratories-Pocono – FDA Inspection, Nov 10, 2015
Record Details
This FDA Inspection record concerns Health Network Laboratories-Pocono, with an inspection on November 10, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 10, 2015
- Product Type
- Biologics
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ID · 21aee19d-ce97-418a-a654-a856fb31f46f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 947800
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.170(a)Adverse reaction - Maintenance of Reports
- 21 CFR 606.160(b)Required records
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.100(b)(9)Written methods for investigating adverse reactions
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Health Network Laboratories-Pocono
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 10, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 11, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 9, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Health Network Laboratories-Pocono
- FDA Inspection 1020349 - 2017-08-01
- FDA Inspection 861764 - 2014-01-10
- FDA Inspection 778733 - 2012-04-11
- FDA Inspection 675180 - 2010-08-09
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