União QuÍmica Farmacêutica Nacional SA
FDA inspection history in GUARULHOS, Brazil, 2012 to 2023
- 2
- Form 483s
- 1
- EIR
Every document, by year
- Form 483
- EIR
2012: one Form 483; 2018: one inspection report; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One Form 483, at GUARULHOS, Brazil.
- 2018One inspection report, at GUARULHOS, Brazil.
- 2023One Form 483, at GUARULHOS, Brazil.
- 2023The longest 483 on file: 2 observations over 4 pages at GUARULHOS, Brazil.
Cited most
Across all União QuÍmica Farmacêutica Nacional observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.198(a)Complaint files1
The complete União QuÍmica Farmacêutica Nacional file.
All 3 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
GUARULHOS, Brazil
Two Form 483s and one inspection report · 2012 to 2023 · 3 observations
Latest: Form 483, Aug 9, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-09 | 483 Form 483 | GUARULHOS, Brazil | 2 | $99 |
| 2018-08-14 | EIR EIR | GUARULHOS, Brazil | — | $550 |
| 2012-12-11 | 483 Form 483 | GUARULHOS, Brazil | 1 | $99 |
Investigators on these documents
Damaris Y. Hernandez (1)E. Melendez (1)Jose E. Melendez (1)Marian E. Ramirez (1)
FEI number 3004063802 · most recent document Aug 9, 2023
About União QuÍmica Farmacêutica Nacional SA
How many FDA Form 483s has União QuÍmica Farmacêutica Nacional SA received?
FDA Intel has 2 Form 483s on file for União QuÍmica Farmacêutica Nacional SA; the most recent is dated Aug 9, 2023.
When was União QuÍmica Farmacêutica Nacional SA last inspected by FDA?
The most recent FDA inspection document on file for União QuÍmica Farmacêutica Nacional SA is a Form 483 dated Aug 9, 2023, for the site in GUARULHOS, Brazil.
What did FDA cite at União QuÍmica Farmacêutica Nacional SA?
The regulations cited most in the observations on file for União QuÍmica Farmacêutica Nacional SA are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.198(a) (Complaint files), 1 time.