Rio Biofarma Brasil Ltda
Form 483 issued May 9, 2024 · Hortolandia, Brazil
- Inspection
- Apr 29 – May 9, 2024
- Investigators
- Ebony D. Sanon· Erin A. Wall· Geoffrey K. Kilili
- Observations
- 7
- Pages
- 11
- FEI number
- 3021095601
In short: On May 9, 2024, FDA issued a Form 483 with 7 observations to Rio Biofarma Brasil Ltda in Hortolandia, Sao Paulo (FEI 3021095601) after an inspection that ran Apr 29 – May 9, 2024. The investigators were Ebony D. Sanon, Erin A. Wall, Geoffrey K. Kilili and Michele L. Glendenning. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Production and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Ebony D. Sanon
8 documents · 2022–2026
Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in Florida.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rio Biofarma Brasil Ltda?
FDA listed 7 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Rio Biofarma Brasil Ltda?
Ebony D. Sanon, Erin A. Wall, Geoffrey K. Kilili and Michele L. Glendenning are named on this Form 483, for the inspection of Apr 29 – May 9, 2024. Each investigator has a profile showing what they cite most.
When was Rio Biofarma Brasil Ltda inspected by FDA?
The inspection ran Apr 29 – May 9, 2024, and the Form 483 is dated May 9, 2024.
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.