Rio Biofarma Brasil Ltda
Form 483 issued August 2, 2022 · Hortolandia, Brazil
- Inspection
- Jul 25 – Aug 2, 2022
- Investigator
- Wayne D. McGrath
- Observations
- 3
- Pages
- 3
- FEI number
- 3021095601
In short: On August 2, 2022, FDA issued a Form 483 with 3 observations to Rio Biofarma Brasil Ltda in Hortolandia, Sao Paulo (FEI 3021095601) after an inspection that ran Jul 25 – Aug 2, 2022. The investigator was Wayne D. McGrath. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Production and quality system account for 2 of 3 observations.
Most cited: 21 CFR 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Laboratory records are deficient in that they do not include a statement of the results of…
This inspection in context
Wayne D. McGrath
33 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmRio Biofarma Brasil Ltda history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rio Biofarma Brasil Ltda?
FDA listed 3 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Rio Biofarma Brasil Ltda?
Wayne D. McGrath is named on this Form 483, for the inspection of Jul 25 – Aug 2, 2022. Each investigator has a profile showing what they cite most.
When was Rio Biofarma Brasil Ltda inspected by FDA?
The inspection ran Jul 25 – Aug 2, 2022, and the Form 483 is dated August 2, 2022.
How do I get the full Form 483 for Rio Biofarma Brasil Ltda?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.