Grifols Therapeutics LLC
Form 483 issued April 1, 2014 · Clayton, North Carolina
- Inspection
- Mar 18 – Apr 1, 2014
- Investigator
- Mihaly S. Ligmond
- Observations
- 5
- Pages
- 4
- FEI number
- 1050373
In short: On April 1, 2014, FDA issued a Form 483 with 5 observations to Grifols Therapeutics LLC in Clayton, North Carolina (FEI 1050373) after an inspection that ran Mar 18 – Apr 1, 2014. The investigator was Mihaly S. Ligmond. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and laboratory controls account for 3 of 5 observations.
Most cited: 21 CFR 211.192 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a lack of assurance that Albumin will remain within specification for appearance…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Media fill vial accountability…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Mihaly S. Ligmond
20 documents · 2006–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
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 5 observations on this Form 483, mostly about production, laboratory controls and quality system. 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?
Mihaly S. Ligmond is named on this Form 483, for the inspection of Mar 18 – Apr 1, 2014. Each investigator has a profile showing what they cite most.
When was Grifols Therapeutics LLC inspected by FDA?
The inspection ran Mar 18 – Apr 1, 2014, and the Form 483 is dated April 1, 2014.
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.