Pf Soins De Sante Sri
Form 483 issued October 27, 2023 · Saint-Laurent, Canada
- Inspection
- Oct 23 – Oct 27, 2023
- Investigator
- Jose M. Cayuela
- Observations
- 2
- Pages
- 4
- FEI number
- 3002806439
In short: On October 27, 2023, FDA issued a Form 483 with 2 observations to Pf Soins De Sante Sri in Saint-Laurent, Quebec (FEI 3002806439) after an inspection that ran Oct 23 – Oct 27, 2023. The investigator was Jose M. Cayuela. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmPf Soins De Sante Sri history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pf Soins De Sante Sri?
FDA listed 2 observations 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 Pf Soins De Sante Sri?
Jose M. Cayuela is named on this Form 483, for the inspection of Oct 23 – Oct 27, 2023. Each investigator has a profile showing what they cite most.
When was Pf Soins De Sante Sri inspected by FDA?
The inspection ran Oct 23 – Oct 27, 2023, and the Form 483 is dated October 27, 2023.
How do I get the full Form 483 for Pf Soins De Sante Sri?
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.