Emballages Spectrum Inc. – FDA Inspection, Nov 6, 2025

Record Details

This FDA Inspection record concerns Emballages Spectrum Inc., with an inspection on November 6, 2025, issued by the Office of Inspections and Investigations, covering human drugs.

Company: Emballages Spectrum Inc.
Inspection Date: November 6, 2025
Product Type: Human Drugs
Office: Office of Inspections and Investigations
Person: Jeffrey P. Raimondi (Investigator)

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ID · a0bc5f00-7a37-4d3f-8dde-bd435ddd3668

Inspection Facts

Inspection number: 1291080
FDA center: Human Drugs
Project area: Generic Drug Evaluation
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.63Equipment Design, Size and Location
21 CFR 211.67(b)Written procedures not established/followed

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FDA Inspection

Emballages Spectrum Inc.November 6, 2025