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FDA Inspection
•Carle Health Care Inc Reproductive Reproductive Windsor•August 15, 2018

Carle Health Care Inc Reproductive Reproductive Windsor – FDA Inspection, Aug 15, 2018

Record Details

This FDA Inspection record concerns Carle Health Care Inc Reproductive Reproductive Windsor, with an inspection on August 15, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Carle Health Care Inc Reproductive Reproductive Windsor
Inspection Date
August 15, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Neali H. Lucas (Company Rep)
  • Uruaku A Obasi (Issuing Officer)
View Company Profile

ID · fbc9e88c-068d-48ee-8742-d7e0398b4248

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1063414
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 1271.90(c)Eligibility not required--warning labels

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Carle Health Care Inc Reproductive Reproductive Windsor

4
DateClassificationOfficeProject area
August 24, 2026NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
November 8, 2022NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
April 11, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
June 13, 2014NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Carle Health Care Inc Reproductive Reproductive Windsor
  • FDA Inspection 1335568 - 2026-08-24
  • FDA Inspection 1190733 - 2022-11-08
  • FDA Inspection 968472 - 2016-04-11
  • FDA Inspection 883128 - 2014-06-13

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