Rio Biofarma Brasil Ltda
FDA inspection history in Hortolandia, Brazil, 2022 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24Two Form 483s, at Hortolandia, Brazil.
- 2024The longest 483 on file: 7 observations over 11 pages at Hortolandia, Brazil.
Cited most
Across all Rio Biofarma Brasil Ltda observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Rio Biofarma Brasil Ltda file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Hortolandia, Brazil
Two Form 483s · 2022 to 2024 · 10 observations
Latest: Form 483, May 9, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-09 | 483 Form 483 | Hortolandia, Brazil | 7 | $99 |
| 2022-08-02 | 483 Form 483 | Hortolandia, Brazil | 3 | $99 |
Investigators on these documents
Ebony D. Sanon (1)Erin A. Wall (1)Geoffrey K. Kilili (1)Michele L. Glendenning (1)Wayne D. McGrath (1)
FEI number 3021095601 · most recent document May 9, 2024
About Rio Biofarma Brasil Ltda
How many FDA Form 483s has Rio Biofarma Brasil Ltda received?
FDA Intel has 2 Form 483s on file for Rio Biofarma Brasil Ltda; the most recent is dated May 9, 2024.
When was Rio Biofarma Brasil Ltda last inspected by FDA?
The most recent FDA inspection document on file for Rio Biofarma Brasil Ltda is a Form 483 dated May 9, 2024, for the site in Hortolandia, Brazil.
What did FDA cite at Rio Biofarma Brasil Ltda?
The regulations cited most in the observations on file for Rio Biofarma Brasil Ltda are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.194 (Laboratory records), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.