FDA Inspection
Rio Biofarma Brasil LtdaRio Biofarma Brasil Ltda – FDA Inspection, May 9, 2024
Record Details
This FDA Inspection record concerns Rio Biofarma Brasil Ltda, with an inspection on May 9, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f20fa1a5-711d-4819-aedc-a0526d5617b9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1238089
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
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