Shine Spect USA, LLC – FDA Inspection, Jul 10, 2026

Record Details

This FDA Inspection record concerns Shine Spect USA, LLC, with an inspection on July 10, 2026, issued by the New England District Office, covering human drugs.

Company: Shine Spect USA, LLC
Inspection Date: July 10, 2026
Product Type: Human Drugs
Office: New England District Office
People: Edmund F. Mrak (FDA Associated Person)
Ifechimere I. Okafor (Company Rep)

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ID · 13ce4487-7ebe-45f3-9015-901681ff21ee

Inspection Facts

Inspection number: 1325866
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 211.46(b)Equipment for Environmental Control
21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance

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FDA Inspection

Shine Spect USA, LLCJuly 10, 2026