Grifols Therapeutics LLC
Form 483 issued October 21, 2016 · Clayton, North Carolina
- Inspection
- Oct 12 – Oct 21, 2016
- Investigators
- Gene Arey· Gene D. Arcy· Mihaly S. Ligmond
- Observations
- 7
- Pages
- 5
- FEI number
- 1050373
In short: On October 21, 2016, FDA issued a Form 483 with 7 observations to Grifols Therapeutics LLC in Clayton, North Carolina (FEI 1050373) after an inspection that ran Oct 12 – Oct 21, 2016. The investigators were Gene Arey, Gene D. Arcy and Mihaly S. Ligmond. 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 5 of 7 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
Your firm has NOT identified a specific cause for leaking/dripping fill lines such that maintenance and/or…
- 02
Observation 2: scanned text, readable in the full document.
- 03
(b) (4) indicates…
- 04
The following written procedures are…
This inspection in context
Gene Arey
6 documents · 2015–2022
Cites 211.192 (production record review) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Grifols Therapeutics LLC?
FDA listed 7 observations on this Form 483, mostly about quality system, production and materials. 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 Therapeutics LLC?
Gene Arey, Gene D. Arcy and Mihaly S. Ligmond are named on this Form 483, for the inspection of Oct 12 – Oct 21, 2016. Each investigator has a profile showing what they cite most.
When was Grifols Therapeutics LLC inspected by FDA?
The inspection ran Oct 12 – Oct 21, 2016, and the Form 483 is dated October 21, 2016.
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.