Team1 LLC – FDA Inspection, Oct 28, 2024

Record Details

This FDA Inspection record concerns Team1 LLC, with an inspection on October 28, 2024, issued by the Florida District Office, covering biologics.

Company: Team1 LLC
Inspection Date: October 28, 2024
Product Type: Biologics
Office: Florida District Office
Person: Barbara T. Carmichael (FDA Associated Person)

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ID · ccc0f7d4-c386-40d5-97de-c606eda1a822

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1252848
FDA center: Biologics
Project area: Human Cellular, Tissue, and Gene Therapies
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 1271.180(a)Procedures to meet core CTGP
21 CFR 1271.190(d)(1)Procedures for cleaning, sanitation
21 CFR 1271.260(e)Periodic review of temperatures

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FDA Inspection

Team1 LLCOctober 28, 2024