Laboratorios Grifols, S.A.
Form 483 issued July 26, 2024 · Parets del Valles, Spain
- Investigator
- Irina Gaberman
- Observations
- 4
- Pages
- 4
- FEI number
- 3009736169
In short: On July 26, 2024, FDA issued a Form 483 with 4 observations to Laboratorios Grifols, S.A. in Parets del Valles, Barcelona (FEI 3009736169). The investigator was 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 observation- 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
Irina Gaberman
8 documents · 2011–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmLaboratorios Grifols, S.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Laboratorios Grifols, S.A.?
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 Laboratorios Grifols, S.A.?
Irina Gaberman is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Laboratorios Grifols, S.A. inspected by FDA?
This Form 483 is dated July 26, 2024.
How do I get the full Form 483 for Laboratorios Grifols, S.A.?
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.