Grifols Therapeutics LLC
FDA inspection history in Clayton, North Carolina, 2014 to 2023
- 5
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2016: one Form 483; 2018: one Form 483; 2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–18Three Form 483s, at Clayton, North Carolina.
- 2018The longest 483 on file: 7 observations over 7 pages at Clayton, North Carolina.
- 2022–23Two Form 483s, at Clayton, North Carolina.
Cited most
Across all Grifols Therapeutics observations on file
- 21 CFR 211.192Production record review6
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.100Written procedures; deviations2
The complete Grifols Therapeutics file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Clayton, North Carolina
Five Form 483s · 2014 to 2023 · 21 observations
Latest: Form 483, Sep 1, 2023 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-01 | 483 Form 483 | Clayton, North Carolina | — | $99 |
| 2022-05-06 | 483 Form 483 | Clayton, North Carolina | 2 | $99 |
| 2018-12-13 | 483 Form 483 | Clayton, North Carolina | 7 | $99 |
| 2016-10-21 | 483 Form 483 | Clayton, North Carolina | 7 | $99 |
| 2014-04-01 | 483 Form 483 | Clayton, North Carolina | 5 | $99 |
Investigators on these documents
Mihaly S. Ligmond (2)Gene D. Arcy (2)Ithia Jim (1)Nesthege Gene Arcy (1)Relerse Bradley Dworak (1)Susan M. Jackson (1)Thia Jim (1)Cynthia Jim (1)Yonggeng Wang (1)Gene Arey (1)
FEI number 1050373 · most recent document Sep 1, 2023
About Grifols Therapeutics LLC
How many FDA Form 483s has Grifols Therapeutics LLC received?
FDA Intel has 5 Form 483s on file for Grifols Therapeutics LLC; the most recent is dated Sep 1, 2023.
When was Grifols Therapeutics LLC last inspected by FDA?
The most recent FDA inspection document on file for Grifols Therapeutics LLC is a Form 483 dated Sep 1, 2023, for the site in Clayton, North Carolina.
What did FDA cite at Grifols Therapeutics LLC?
The regulations cited most in the observations on file for Grifols Therapeutics LLC are 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times.