FANCYSTAGE, UNIPESSOAL, LDA. – FDA Inspection, Jan 26, 2024

Record Details

This FDA Inspection record concerns FANCYSTAGE, UNIPESSOAL, LDA., with an inspection on January 26, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: FANCYSTAGE, UNIPESSOAL, LDA.
Inspection Date: January 26, 2024
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Bijoy Panicker

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ID · edd9482a-c600-4dd3-a5bf-6833d244852a

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1227903
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
21 CFR 211.165(e)Test methods
21 CFR 211.192Investigations of discrepancies, failures
21 CFR 211.122(a)Written procedures describing in detail
21 CFR 211.166(a)Lack of written stability program
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.100(a)Absence of Written Procedures

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FDA Inspection

FANCYSTAGE, UNIPESSOAL, LDA.January 26, 2024