ROVI Pharma Industrial Services S.A.
Form 483 issued April 22, 2016 · Madrid, Spain
- Inspection
- Apr 14 – Apr 22, 2016
- Investigators
- Ademola O. Daramola· Xiomara Copeland
- Observations
- 3
- Pages
- 3
- FEI number
- 3007512884
In short: On April 22, 2016, FDA issued a Form 483 with 3 observations to ROVI Pharma Industrial Services S.A. in Madrid, Spain (FEI 3007512884) after an inspection that ran Apr 14 – Apr 22, 2016. The investigators were Ademola O. Daramola and Xiomara Copeland. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Ademola O. Daramola
11 documents · 2014–2018
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmROVI Pharma Industrial Services S.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ROVI Pharma Industrial Services S.A.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected ROVI Pharma Industrial Services S.A.?
Ademola O. Daramola and Xiomara Copeland are named on this Form 483, for the inspection of Apr 14 – Apr 22, 2016. Each investigator has a profile showing what they cite most.
When was ROVI Pharma Industrial Services S.A. inspected by FDA?
The inspection ran Apr 14 – Apr 22, 2016, and the Form 483 is dated April 22, 2016.
How do I get the full Form 483 for ROVI Pharma Industrial Services S.A.?
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