Form 483 · FEI 3009713694
Form 483 issued June 14, 2019 · Toledo, Spain
- Inspection
- Jun 3 – Jun 14, 2019
- Investigators
- Darren S. Brown· Junho Pak
- Observations
- 4
- Pages
- 6
- FEI number
- 3009713694
In short: On June 14, 2019, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Toledo, Spain (FEI 3009713694) after an inspection that ran Jun 3 – Jun 14, 2019. The investigators were Darren S. Brown and Junho Pak. Most observations concern quality system and production.
At a glance
Quality system and production 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmSite history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Darren S. Brown and Junho Pak are named on this Form 483, for the inspection of Jun 3 – Jun 14, 2019. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jun 3 – Jun 14, 2019, and the Form 483 is dated June 14, 2019.
How do I get the full Form 483 for an FDA-inspected site?
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.