Les Produits Chimiques B.G.R. Inc.
Form 483 issued September 27, 2017 · Pointe-Claire, Canada
- Inspection
- Sep 25 – Sep 27, 2017
- Investigator
- Jose A. Cruz-Gonzalez
- Observations
- 13
- Pages
- 3
- FEI number
- 3000287309
In short: On September 27, 2017, FDA issued a Form 483 with 13 observations to Les Produits Chimiques B.G.R. Inc. in Pointe-Claire, Quebec (FEI 3000287309) after an inspection that ran Sep 25 – Sep 27, 2017. The investigator was Jose A. Cruz-Gonzalez. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and facilities & equipment account for 9 of 13 observations.
Most cited: 21 CFR 211.194 (3×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
QC release tests Identification A and Identification B, which are required in the firm’s QC testing…
- 02
Details about the execution of several analytical testing methods used for the release of Powder USP…
- 03
Observation 3: scanned text, readable in the full document.
- 04
The firm does not have an established sampling plan to assure that samples of raw materials…
This inspection in context
Jose A. Cruz-Gonzalez
11 documents · 2013–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmLes Produits Chimiques B.G.R. Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Les Produits Chimiques B.G.R. Inc.?
FDA listed 13 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Les Produits Chimiques B.G.R. Inc.?
Jose A. Cruz-Gonzalez is named on this Form 483, for the inspection of Sep 25 – Sep 27, 2017. Each investigator has a profile showing what they cite most.
When was Les Produits Chimiques B.G.R. Inc. inspected by FDA?
The inspection ran Sep 25 – Sep 27, 2017, and the Form 483 is dated September 27, 2017.
How do I get the full Form 483 for Les Produits Chimiques B.G.R. Inc.?
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.