FDA Inspection

Betone, S.A. de C.V.November 10, 2023

Betone, S.A. de C.V. – FDA Inspection, Nov 10, 2023

Record Details

This FDA Inspection record concerns Betone, S.A. de C.V., with an inspection on November 10, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Betone, S.A. de C.V.
Inspection Date: November 10, 2023
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Jonathan G. Matrisciano (FDA Associated Person)

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ID · 856c522c-0d80-48af-8819-a98ed6aa082a

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1223539
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.122(d)Label storage access limited to authorized personnel
21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
21 CFR 211.101(c)Weighing/measuring/subdividing supervision
21 CFR 211.101(d)Component addition checked by 2nd person
21 CFR 211.84(a)Components withheld from use pending release
21 CFR 211.165(a)Testing and release for distribution
21 CFR 211.166(a)Lack of written stability program
21 CFR 211.170(b)(1)Reserve sample retention time
21 CFR 211.101(a)Batches Formulated to less than 100%
21 CFR 211.101(a)Batches Formulated to less than 100%

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