Delpharm Montreal Inc.
Form 483 issued September 1, 2023 · Pointe-Claire, Canada
- Inspection
- Aug 28 – Sep 1, 2023
- Investigator
- Bryan L. McGuckin
- Observations
- 4
- Pages
- 3
- FEI number
- 3002808099
In short: On September 1, 2023, FDA issued a Form 483 with 4 observations to Delpharm Montreal Inc. in Pointe-Claire, Quebec (FEI 3002808099) after an inspection that ran Aug 28 – Sep 1, 2023. The investigator was Bryan L. McGuckin. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 211.208
Salvaging operations on drug products which may have been subjected to improper storage conditions proceeded in…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Routine checking of electronic equipment is not performed according to a written program designed…
- 04
Established laboratory control mechanisms are not documented at…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmDelpharm Montreal Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Delpharm Montreal Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Delpharm Montreal Inc.?
Bryan L. McGuckin is named on this Form 483, for the inspection of Aug 28 – Sep 1, 2023. Each investigator has a profile showing what they cite most.
When was Delpharm Montreal Inc. inspected by FDA?
The inspection ran Aug 28 – Sep 1, 2023, and the Form 483 is dated September 1, 2023.
How do I get the full Form 483 for Delpharm Montreal 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.