Urquima, S.A.
Form 483 issued September 29, 2016 · Sant Fost de Campsentelles, Spain
- Inspection
- Apr 26 – Sep 29, 2016
- Investigator
- Steven D. Kehoe
- Observations
- 2
- Pages
- 3
- FEI number
- 3002808432
In short: On September 29, 2016, FDA issued a Form 483 with 2 observations to Urquima, S.A. in Sant Fost de Campsentelles, BA (FEI 3002808432) after an inspection that ran Apr 26 – Sep 29, 2016. The investigator was Steven D. Kehoe. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Written procedures are not established or followed for the cleaning and maintenance of equipment used in…
This inspection in context
Steven D. Kehoe
4 documents · 2015–2016
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmUrquima, S.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Urquima, S.A.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Urquima, S.A.?
Steven D. Kehoe is named on this Form 483, for the inspection of Apr 26 – Sep 29, 2016. Each investigator has a profile showing what they cite most.
When was Urquima, S.A. inspected by FDA?
The inspection ran Apr 26 – Sep 29, 2016, and the Form 483 is dated September 29, 2016.
How do I get the full Form 483 for Urquima, S.A.?
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.