Grifols Biologicals LLC
FDA inspection history in City of Industry, California, 2017 to 2019
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at City of Industry, California.
- 2019The longest 483 on file: 6 observations over 4 pages at City of Industry, California.
Cited most
Across all Grifols Biologicals observations on file
- 21 CFR 211.130Packaging and labeling operations1
- 21 CFR 211.134Drug product inspection1
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.42Design and construction features1
The complete Grifols Biologicals file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
City of Industry, California
Two Form 483s · 2017 to 2019 · 9 observations
Latest: Form 483, Sep 12, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-09-12 | 483 Form 483 | City of Industry, California | 6 | $99 |
| 2017-08-22 | 483 Form 483 | City of Industry, California | 3 | $99 |
Investigators on these documents
Decarlos A. Gomez (1)Gene D. Arcy (1)Malgorzata G. Norton (1)Nobuko Katagiri (1)Olga Simakova (1)Omotunde O. Osunsanmi (1)Vijaya Simhadri (1)
FEI number 2077802 · most recent document Sep 12, 2019
About Grifols Biologicals LLC
How many FDA Form 483s has Grifols Biologicals LLC received?
FDA Intel has 2 Form 483s on file for Grifols Biologicals LLC; the most recent is dated Sep 12, 2019.
When was Grifols Biologicals LLC last inspected by FDA?
The most recent FDA inspection document on file for Grifols Biologicals LLC is a Form 483 dated Sep 12, 2019, for the site in City of Industry, California.
What did FDA cite at Grifols Biologicals LLC?
The regulations cited most in the observations on file for Grifols Biologicals LLC are 21 CFR 211.130 (Packaging and labeling operations), 1 time; 21 CFR 211.134 (Drug product inspection), 1 time; 21 CFR 211.142 (Warehousing procedures), 1 time.