Grifols Therapeutics LLC
Form 483 issued December 13, 2018 · Clayton, North Carolina
- Inspection
- Dec 5 – Dec 13, 2018
- Investigators
- Cynthia Jim· Ithia Jim· Thia Jim
- Observations
- 7
- Pages
- 7
- FEI number
- 1050373
In short: On December 13, 2018, FDA issued a Form 483 with 7 observations to Grifols Therapeutics LLC in Clayton, North Carolina (FEI 1050373) after an inspection that ran Dec 5 – Dec 13, 2018. The investigators were Cynthia Jim, Ithia Jim and Thia Jim. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Quality system and facilities & equipment account for 5 of 7 observations.
Most cited: 21 CFR 211.42 (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 failure to thoroughly review unexplained discrepancies whether or not the batch…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Visual inspection and visual…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) 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 211.42
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, facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Grifols Therapeutics LLC?
Cynthia Jim, Ithia Jim and Thia Jim are named on this Form 483, for the inspection of Dec 5 – Dec 13, 2018. Each investigator has a profile showing what they cite most.
When was Grifols Therapeutics LLC inspected by FDA?
The inspection ran Dec 5 – Dec 13, 2018, and the Form 483 is dated December 13, 2018.
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.