Les Produits Chimiques B.G.R. Inc.
Form 483 issued February 28, 2025 · Pointe-Claire, Canada
- Inspection
- Feb 24 – Feb 28, 2025
- Investigators
- Robin P. Mathew· Soyinka S. Eneng
- Observations
- 3
- Pages
- 3
- FEI number
- 3000287309
In short: On February 28, 2025, FDA issued a Form 483 with 3 observations to Les Produits Chimiques B.G.R. Inc. in Pointe-Claire, Quebec (FEI 3000287309) after an inspection that ran Feb 24 – Feb 28, 2025. The investigators were Robin P. Mathew and Soyinka S. Eneng. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.63 (1×) · 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
1. Equipment used in the manufacture, processing, packing or holding of active pharmaceutical ingredients is not…
- 02
1. The suitability of test methods for active pharmaceutical ingredients have not been verified under…
- 03
USP, lot # o…
This inspection in context
Robin P. Mathew
11 documents · 2020–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
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 211.63
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 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Les Produits Chimiques B.G.R. Inc.?
Robin P. Mathew and Soyinka S. Eneng are named on this Form 483, for the inspection of Feb 24 – Feb 28, 2025. 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 Feb 24 – Feb 28, 2025, and the Form 483 is dated February 28, 2025.
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.