Grifols Therapeutics LLC
Form 483 issued May 6, 2022 · Clayton, North Carolina
- Investigators
- Gene D. Arcy· Nesthege Gene Arcy· Susan M. Jackson
- Observations
- 2
- Pages
- 4
- FEI number
- 1050373
In short: On May 6, 2022, FDA issued a Form 483 with 2 observations to Grifols Therapeutics LLC in Clayton, North Carolina (FEI 1050373). The investigators were Gene D. Arcy, Nesthege Gene Arcy and Susan M. Jackson. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug product purporting to be sterile are not…
- 02
Bioburden monitoring of manufacturing processes leading to the production of pre-sterile bulks…
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 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Grifols Therapeutics LLC?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Grifols Therapeutics LLC?
Gene D. Arcy, Nesthege Gene Arcy and Susan M. Jackson 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 May 6, 2022.
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.