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FDA Inspection
•ProHealth Care Laboratoreies•July 11, 2018

ProHealth Care Laboratoreies – FDA Inspection, Jul 11, 2018

Record Details

This FDA Inspection record concerns ProHealth Care Laboratoreies, with an inspection on July 11, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
ProHealth Care Laboratoreies
Inspection Date
July 11, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Susan M North (Issuing Officer)
View Company Profile

ID · 36c8cb49-8e65-4bca-858f-ee06a5d16598

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1058585
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 606.170(a)Adverse Reaction - Investigations

Full citation text and observation details available on the Dashboard.

Other FDA inspections of ProHealth Care Laboratoreies

4
DateClassificationOfficeProject area
August 22, 2022NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
April 6, 2016NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 25, 2013VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 28, 2011NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for ProHealth Care Laboratoreies
  • FDA Inspection 1178716 - 2022-08-22
  • FDA Inspection 974129 - 2016-04-06
  • FDA Inspection 857115 - 2013-11-25
  • FDA Inspection 755381 - 2011-11-28

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