Les Produits Chimiques B.G.R. Inc.

Form 483 issued January 11, 2019 · Pointe-Claire, Canada

Inspection: Jan 7 – Jan 11, 2019
Investigator: Stephanie A. Slater
Observations: 9
Pages: 6
FEI number: 3000287309

In short: On January 11, 2019, FDA issued a Form 483 with 9 observations to Les Produits Chimiques B.G.R. Inc. in Pointe-Claire, Quebec (FEI 3000287309) after an inspection that ran Jan 7 – Jan 11, 2019. The investigator was Stephanie A. Slater. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).

At a glance

Laboratory controls and materials account for 7 of 9 observations.

Laboratory controls5

Materials2

Facilities & equipment1

Production1

Most cited: 21 CFR 211.84 (2×) · 211.194 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.84
Your firm’s Quality Assurance (QA) does not always approve raw materials for release before they are…
02
21 CFR 211.67 21 CFR 211.182
PLO ocared in Komi Validation and PLOW cleaning procedures for the ah and DON Room in…
03
21 CFR 211.84
Your firm did not implement, use, or document any established raw material sampling plans from approximately…
04
21 CFR 211.188 21 CFR 211.100
Batch production records tel oe Powder have specific manufacturing instructions that are not always documented and…

5 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Stephanie A. Slater

20 documents · 2015–2021

Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.

The firm

Les 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 483s

Other sites cited under 211.84

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 9 observations on this Form 483, mostly about laboratory controls, materials and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.

Who inspected Les Produits Chimiques B.G.R. Inc.?

Stephanie A. Slater is named on this Form 483, for the inspection of Jan 7 – Jan 11, 2019. 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 Jan 7 – Jan 11, 2019, and the Form 483 is dated January 11, 2019.

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.