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FDA Inspection
•Health Network Laboratories LP•April 25, 2019

Health Network Laboratories LP – FDA Inspection, Apr 25, 2019

Record Details

This FDA Inspection record concerns Health Network Laboratories LP, with an inspection on April 25, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Health Network Laboratories LP
Inspection Date
April 25, 2019
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Cara M. Minelli (Issuing Officer)
View Company Profile

ID · 029144c9-f0f3-4151-9948-e602d7723184

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1088201
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 600.15Blood & Blood Components
  2. 21 CFR 606.160(a)(1)Person performing, test results, interpretation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Health Network Laboratories LP

5
DateClassificationOfficeProject area
August 20, 2024NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 2, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 21, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 29, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 7, 2010NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Health Network Laboratories LP
  • FDA Inspection 1251286 - 2024-08-20
  • FDA Inspection 1010559 - 2017-05-02
  • FDA Inspection 927308 - 2015-05-21
  • FDA Inspection 835279 - 2013-05-29
  • FDA Inspection 665477 - 2010-06-07

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Contact
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370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
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201 Lackawanna Avenue
Scranton, PA, 18503
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