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FDA Inspection
•Burkhart Dental Supply Co (The)•August 21, 2017

Burkhart Dental Supply Co (The) – FDA Inspection, Aug 21, 2017

Record Details

This FDA Inspection record concerns Burkhart Dental Supply Co (The), with an inspection on August 21, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Burkhart Dental Supply Co (The)
Inspection Date
August 21, 2017
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Decarlos A. Gomez (Issuing Officer)
  • Elmina E Akwo (Issuing Officer)
View Company Profile

ID · 477a3709-f41f-49b8-b205-d4e73e7ffde6

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1022605
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 1271.180(a)Procedures to meet core CTGP
  2. 21 CFR 1271.265(a)Evaluation--microorganisms, damage
  3. 21 CFR 1271.265(f)Return to inventory--procedures
  4. 21 CFR 1271.270(d)Retention time (10 year rules)

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Burkhart Dental Supply Co (The)

1
DateClassificationOfficeProject area
June 3, 2025NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Burkhart Dental Supply Co (The)
  • FDA Inspection 1272293 - 2025-06-03

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