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FDA Inspection
•AVEM Labs LLC•May 21, 2025

AVEM Labs LLC – FDA Inspection, May 21, 2025

Record Details

This FDA Inspection record concerns AVEM Labs LLC, with an inspection on May 21, 2025, issued by the San Francisco District Office, covering biologics.

Company
AVEM Labs LLC
Inspection Date
May 21, 2025
Product Type
Biologics
Office
San Francisco District Office
People
  • Garrad R. Poole (Investigator)
  • Laurissa S. Flowers (Issuing Officer)
View Company Profile

ID · 3bc00813-b406-4334-bacf-7478373d1527

Inspection Facts

Inspection number
1270448
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued, view the record

FDA Citations

5
  1. 21 CFR 1271.200(c)Calibrated per established schedules
  2. 21 CFR 1271.210(d)(1)Receipt documentation maintained
  3. 21 CFR 1271.230(a)Validation & approval--established procedures
  4. 21 CFR 1271.250(b)Verification of label accuracy, legibility, integrity
  5. 21 CFR 1271.55(d)(4)Ten year retention

Full citation text and observation details available on the Dashboard.

Other FDA inspections of AVEM Labs LLC

1
DateClassificationOfficeProject area
November 22, 2022VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for AVEM Labs LLC
  • FDA Inspection 1191152 - 2022-11-22

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