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FDA Inspection
•Carter BloodCare - Baylor•July 25, 2019

Carter BloodCare - Baylor – FDA Inspection, Jul 25, 2019

Record Details

This FDA Inspection record concerns Carter BloodCare - Baylor, with an inspection on July 25, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Carter BloodCare - Baylor
Inspection Date
July 25, 2019
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Nimmy Mathews (FDA Associated Person)
View Company Profile

ID · 8c27a9f0-557c-400c-9909-7ccb807c1d1b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1098356
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 606.160(b)Required records

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Carter BloodCare - Baylor

6
DateClassificationOfficeProject area
April 26, 2024NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 6, 2017Not classifiedDallas District Office
May 20, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 7, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 8, 2011NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for Carter BloodCare - Baylor
  • FDA Inspection 1237401 - 2024-04-26
  • FDA Inspection 997964 - 2017-01-06
  • FDA Inspection 927574 - 2015-05-20
  • FDA Inspection 818049 - 2013-02-07
  • FDA Inspection 733844 - 2011-07-08

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