Moehs Catalana SL
Form 483 issued May 18, 2018 · Rubi, Spain
- Inspection
- May 14 – May 18, 2018
- Investigator
- Anastasia M. Shields
- Observations
- 1
- Pages
- 3
- FEI number
- 3002807632
In short: On May 18, 2018, FDA issued a Form 483 with 1 observation to Moehs Catalana SL in Rubi, Barcelona (FEI 3002807632) after an inspection that ran May 14 – May 18, 2018. The investigator was Anastasia M. Shields. 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×) · 211.160 (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…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmMoehs Catalana SL 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 Moehs Catalana SL?
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 Moehs Catalana SL?
Anastasia M. Shields is named on this Form 483, for the inspection of May 14 – May 18, 2018. Each investigator has a profile showing what they cite most.
When was Moehs Catalana SL inspected by FDA?
The inspection ran May 14 – May 18, 2018, and the Form 483 is dated May 18, 2018.
How do I get the full Form 483 for Moehs Catalana SL?
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.