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FDA Inspection
•Image Supply Inc•January 8, 2025

Image Supply Inc – FDA Inspection, Jan 8, 2025

Record Details

This FDA Inspection record concerns Image Supply Inc, with an inspection on January 8, 2025, issued by the Atlanta District Office, covering human drugs.

Company
Image Supply Inc
Inspection Date
January 8, 2025
Product Type
Human Drugs
Office
Atlanta District Office
People
  • Jared P. Stevens (FDA Associated Person)
  • Samantha E. Cleek (Investigator)
View Company Profile

ID · b51fa20a-7925-4e4e-8987-5e98e2d9a872

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1258201
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

6
  1. 21 CFR 211.137(a)Expiration date lacking
  2. 21 CFR 211.25(a)Training--operations, GMPs, written procedures
  3. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
  4. 21 CFR 211.122(a)Written procedures describing in detail
  5. 21 CFR 211.22(a)Lack of quality control unit
  6. 21 CFR 211.100(a)Absence of Written Procedures

Full citation text and observation details available on the Dashboard.

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