Erkul Kozmetik Sanayi ve Ticaret A.S. – FDA Inspection, Sep 27, 2024

Record Details

This FDA Inspection record concerns Erkul Kozmetik Sanayi ve Ticaret A.S., with an inspection on September 27, 2024, issued by the Office of Inspections and Investigations, covering human drugs.

Company: Erkul Kozmetik Sanayi ve Ticaret A.S.
Inspection Date: September 27, 2024
Product Type: Human Drugs
Office: Office of Inspections and Investigations
Person: Truong X. Nguyen (FDA Associated Person)

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ID · a1fa2d34-32e6-4546-91e4-4b09637a4ad3

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1250170
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.182Chronological Order of Equipment Log Entries
21 CFR 211.22(d)Procedures not in writing, fully followed

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FDA Inspection

Erkul Kozmetik Sanayi ve Ticaret A.S.September 27, 2024