Form 483 · FEI 3007308769
Form 483 issued August 5, 2022 · Modra, Slovakia
- Inspection
- Aug 1 – Aug 5, 2022
- Investigator
- Ariel Cruz Figueroa
- Observations
- 1
- Pages
- 2
- FEI number
- 3007308769
In short: On August 5, 2022, FDA issued a Form 483 with 1 observation to an FDA-inspected site in Modra, Slovakia (FEI 3007308769) after an inspection that ran Aug 1 – Aug 5, 2022. The investigator was Ariel Cruz Figueroa. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Ariel Cruz Figueroa is named on this Form 483, for the inspection of Aug 1 – Aug 5, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Aug 1 – Aug 5, 2022, and the Form 483 is dated August 5, 2022.
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.