Grifols Therapeutics LLC
Form 483 issued September 1, 2023 · Clayton, North Carolina
- Investigators
- Relerse Bradley Dworak· Yonggeng Wang
- Observations
- 5
- Pages
- 2
- FEI number
- 1050373
In short: On September 1, 2023, FDA issued a Form 483 with 5 observations to Grifols Therapeutics LLC in Clayton, North Carolina (FEI 1050373). The investigators were Relerse Bradley Dworak and Yonggeng Wang. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 3 of 5 observations.
Most cited: 21 CFR 211.68 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inadequate control of production…
- 02
Preventive maintenance schedules for equipment are not properly followed and/or…
- 03
Written procedures were not…
- 04
Failure to maintain freezer used for(B)(4)pf laboratory per coe including (b)(A)and…
This inspection in context
Relerse Bradley Dworak
1 document · 2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in North Carolina.
The firmGrifols Therapeutics LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Grifols Therapeutics LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Grifols Therapeutics LLC?
Relerse Bradley Dworak and Yonggeng Wang are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Grifols Therapeutics LLC inspected by FDA?
This Form 483 is dated September 1, 2023.
How do I get the full Form 483 for Grifols Therapeutics 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.