Grifols Biologicals LLC
Form 483 issued September 12, 2019 · Los Angeles, California
- Inspection
- Aug 27 – Sep 12, 2019
- Investigators
- Of Is Chisne Wa· Onus Bm
- Observations
- 12
- Pages
- 10
- FEI number
- 2080769
In short: On September 12, 2019, FDA issued a Form 483 with 12 observations to Grifols Biologicals LLC in Los Angeles, California (FEI 2080769) after an inspection that ran Aug 27 – Sep 12, 2019. The investigators were Of Is Chisne Wa and Onus Bm. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 8 of 12 observations.
Most cited: 21 CFR 211.192 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitors the output and validated performance of those manufacturing processes…
- 02
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 03
Failure to submit a supplement prior to distributing product…
- 04
There is a failure to thoroughly review any unexplained discrepancy, the failure of a batch or…
This inspection in context
Of Is Chisne Wa
1 document · 2019
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Grifols Biologicals LLC?
FDA listed 12 observations on this Form 483, mostly about quality system, production and laboratory controls. 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 Grifols Biologicals LLC?
Of Is Chisne Wa and Onus Bm are named on this Form 483, for the inspection of Aug 27 – Sep 12, 2019. Each investigator has a profile showing what they cite most.
When was Grifols Biologicals LLC inspected by FDA?
The inspection ran Aug 27 – 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.