União QuÍmica Farmacêutica Nacional SA
Form 483 issued December 11, 2012 · GUARULHOS, Brazil
- Inspection
- Dec 3 – Dec 11, 2012
- Investigator
- E. Melendez
- Observations
- 1
- Pages
- 1
- FEI number
- 3004063802
In short: On December 11, 2012, FDA issued a Form 483 with 1 observation to União QuÍmica Farmacêutica Nacional SA in GUARULHOS, SP (FEI 3004063802) after an inspection that ran Dec 3 – Dec 11, 2012. The investigator was E. Melendez. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
E. Melendez
1 document · 2012
Cites 211.113(b) (control of microbiological contamination) more than any other section. Most of their documents are for sites in Brazil.
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 211.113(b)
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 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected União QuÍmica Farmacêutica Nacional SA?
E. Melendez is named on this Form 483, for the inspection of Dec 3 – Dec 11, 2012. Each investigator has a profile showing what they cite most.
When was União QuÍmica Farmacêutica Nacional SA inspected by FDA?
The inspection ran Dec 3 – Dec 11, 2012, and the Form 483 is dated December 11, 2012.
How do I get the full Form 483 for União QuÍmica Farmacêutica Nacional SA?
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.