Grifols Biologicals LLC
Form 483 issued September 12, 2019 · City of Industry, California
- Inspection
- Sep 4 – Sep 12, 2019
- Investigators
- Decarlos A. Gomez· Malgorzata G. Norton· Nobuko Katagiri
- Observations
- 6
- Pages
- 4
- FEI number
- 2077802
In short: On September 12, 2019, FDA issued a Form 483 with 6 observations to Grifols Biologicals LLC in City of Industry, California (FEI 2077802) after an inspection that ran Sep 4 – Sep 12, 2019. The investigators were Decarlos A. Gomez, Malgorzata G. Norton, Nobuko Katagiri, Olga Simakova, Omotunde O. Osunsanmi and Vijaya Simhadri. Most observations concern facilities & equipment and packaging & labeling; the most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling).
At a glance
Facilities & equipment and packaging & labeling account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
- 02
Inspections of the manufactured products vial visual inspection, labeling, and packaging areas are inadequate before and…
- 03
Equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing…
- 04
Procedures describing the warehousing of drug…
This inspection in context
Decarlos A. Gomez
1 document · 2019
Cites 211.130 (packaging and labeling operations) 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Grifols Biologicals LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, packaging & labeling and materials. The most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling). The opening words of each observation are shown on this page.
Who inspected Grifols Biologicals LLC?
Decarlos A. Gomez, Malgorzata G. Norton, Nobuko Katagiri, Olga Simakova, Omotunde O. Osunsanmi and Vijaya Simhadri are named on this Form 483, for the inspection of Sep 4 – Sep 12, 2019. Each investigator has a profile showing what they cite most.
When was Grifols Biologicals LLC inspected by FDA?
The inspection ran Sep 4 – Sep 12, 2019, and the Form 483 is dated September 12, 2019.
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.