Instituto Grifols, S.A.
Form 483 issued June 25, 2019 · Parets Del Valles, Spain
- Inspection
- May 6 – Jun 25, 2019
- Investigator
- Gene Arey
- Observations
- 2
- Pages
- 2
- FEI number
- 3002807257
In short: On June 25, 2019, FDA issued a Form 483 with 2 observations to Instituto Grifols, S.A. in Parets Del Valles, Spain (FEI 3002807257) after an inspection that ran May 6 – Jun 25, 2019. The investigator was Gene Arey. Most observations concern quality system and biologics CGMP; the most-cited regulation is 21 CFR 600.80 (postmarketing reporting of adverse experiences).
At a glance
Quality system and biologics cgmp account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Quality Unit lacks authority to fully investigate…
- 02
Regarding the follow-up of adverse experiences, investigations…
This inspection in context
Gene Arey
6 documents · 2015–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
The firmInstituto Grifols, S.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Instituto Grifols, S.A.?
FDA listed 2 observations on this Form 483, mostly about quality system and biologics CGMP. The most-cited regulation is 21 CFR 600.80 (postmarketing reporting of adverse experiences). The opening words of each observation are shown on this page.
Who inspected Instituto Grifols, S.A.?
Gene Arey is named on this Form 483, for the inspection of May 6 – Jun 25, 2019. Each investigator has a profile showing what they cite most.
When was Instituto Grifols, S.A. inspected by FDA?
The inspection ran May 6 – Jun 25, 2019, and the Form 483 is dated June 25, 2019.
How do I get the full Form 483 for Instituto Grifols, 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.