União QuÍmica Farmacêutica Nacional SA
Form 483 issued August 9, 2023 · GUARULHOS, Brazil
- Inspection
- Jul 31 – Aug 9, 2023
- Investigators
- Damaris Y. Hernandez· Marian E. Ramirez
- Observations
- 2
- Pages
- 4
- FEI number
- 3004063802
In short: On August 9, 2023, FDA issued a Form 483 with 2 observations to União QuÍmica Farmacêutica Nacional SA in GUARULHOS, SP (FEI 3004063802) after an inspection that ran Jul 31 – Aug 9, 2023. The investigators were Damaris Y. Hernandez and Marian E. Ramirez. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.198(a) (1×) · 211.110(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures describing the handling of complaints do not include provisions for review by the quality…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Damaris Y. Hernandez
17 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmUnião QuÍmica Farmacêutica Nacional SA history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at União QuÍmica Farmacêutica Nacional SA?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected União QuÍmica Farmacêutica Nacional SA?
Damaris Y. Hernandez and Marian E. Ramirez are named on this Form 483, for the inspection of Jul 31 – Aug 9, 2023. Each investigator has a profile showing what they cite most.
When was União QuÍmica Farmacêutica Nacional SA inspected by FDA?
The inspection ran Jul 31 – Aug 9, 2023, and the Form 483 is dated August 9, 2023.
How do I get the full Form 483 for União QuÍmica Farmacêutica Nacional SA?
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