FDA Form 438 Grifols, Barcelona, Spain, July 2024
Form 483 issued July 26, 2024 · Paret s Del Valles
- Inspection
- Jul 22 – Jul 26, 2024
- Investigators
- Irin A. Gaberman· Irina Gaberman
- Observations
- 4
- Pages
- 4
In short: On July 26, 2024, FDA issued a Form 483 with 4 observations to FDA Form 438 Grifols, Barcelona, Spain, July 2024 in Paret s Del Valles after an inspection that ran Jul 22 – Jul 26, 2024. The investigators were Irin A. Gaberman and Irina Gaberman. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
The batch production and control records are deficient in that they do not include documentation of…
- 03
Laboratory records are deficient in that they do not include a complete record of all…
- 04
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
This inspection in context
Irin A. Gaberman
1 document · 2024
Cites 211.100 (written procedures; deviations) more than any other section.
The firmFDA Form 438 Grifols, Barcelona, Spain, July 2024 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 438 Grifols, Barcelona, Spain, July 2024?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected FDA Form 438 Grifols, Barcelona, Spain, July 2024?
Irin A. Gaberman and Irina Gaberman are named on this Form 483, for the inspection of Jul 22 – Jul 26, 2024. Each investigator has a profile showing what they cite most.
When was FDA Form 438 Grifols, Barcelona, Spain, July 2024 inspected by FDA?
The inspection ran Jul 22 – Jul 26, 2024, and the Form 483 is dated July 26, 2024.
How do I get the full Form 483 for FDA Form 438 Grifols, Barcelona, Spain, July 2024?
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.