MARSHALLS TRADITIONAL HEALTHCARE CC – FDA Inspection, Sep 23, 2024

Record Details

This FDA Inspection record concerns MARSHALLS TRADITIONAL HEALTHCARE CC, with an inspection on September 23, 2024, issued by the Office of Inspections and Investigations, covering human drugs.

Company: MARSHALLS TRADITIONAL HEALTHCARE CC
Inspection Date: September 23, 2024
Product Type: Human Drugs
Office: Office of Inspections and Investigations
People: Josh Renzo N. Ramilo (Issuing Officer)
Justin A. Boyd (Investigator)

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ID · 77601de7-2d2b-4cf6-a113-6dc1543f2606

Inspection Facts

Inspection number: 1249880
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.111Establishment of time limitations
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.165(a)Testing and release for distribution
21 CFR 211.165(b)Microbiological testing
21 CFR 211.63Equipment Design, Size and Location
21 CFR 211.67(b)Written procedures not established/followed
21 CFR 211.84(d)(1)Component identity verification

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FDA Inspection

MARSHALLS TRADITIONAL HEALTHCARE CCSeptember 23, 2024