Grifols Biologicals LLC
Form 483 issued August 22, 2017 · City of Industry, California
- Inspection
- Aug 22, 2017
- Investigator
- Gene D. Arcy
- Observations
- 3
- Pages
- 2
- FEI number
- 2077802
In short: On August 22, 2017, FDA issued a Form 483 with 3 observations to Grifols Biologicals LLC in City of Industry, California (FEI 2077802) after an inspection that ran Aug 22, 2017. The investigator was Gene D. Arcy. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.58 (maintenance).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.58 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A building used in the packing and holding of a drug product was not maintained in…
- 02
It is understood and expected that a sister corporation occupying the same building is responsible for…
- 03
Operations personnel use a Work Order form/process that is not associated with a formal procedure. However…
This inspection in context
Gene D. Arcy
16 documents · 2003–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmGrifols Biologicals LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Grifols Biologicals LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.58 (maintenance). The opening words of each observation are shown on this page.
Who inspected Grifols Biologicals LLC?
Gene D. Arcy is named on this Form 483, for the inspection of Aug 22, 2017. Each investigator has a profile showing what they cite most.
When was Grifols Biologicals LLC inspected by FDA?
The inspection ran Aug 22, 2017, and the Form 483 is dated August 22, 2017.
How do I get the full Form 483 for Grifols Biologicals LLC?
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.