Air Liquide Canada Inc.
Form 483 issued March 13, 2020 · Hamilton, Canada
- Inspection
- Mar 9 – Mar 13, 2020
- Investigator
- Yasamin Ameri
- Observations
- 11
- Pages
- 5
- FEI number
- 3001774291
In short: On March 13, 2020, FDA issued a Form 483 with 11 observations to Air Liquide Canada Inc. in Hamilton, Ontario (FEI 3001774291) after an inspection that ran Mar 9 – Mar 13, 2020. The investigator was Yasamin Ameri. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
7 of 11 observations on this 483 concern quality system.
Most cited: 21 CFR 211.25(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
The firmAir Liquide Canada Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Air Liquide Canada Inc.?
FDA listed 11 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Air Liquide Canada Inc.?
Yasamin Ameri is named on this Form 483, for the inspection of Mar 9 – Mar 13, 2020. Each investigator has a profile showing what they cite most.
When was Air Liquide Canada Inc. inspected by FDA?
The inspection ran Mar 9 – Mar 13, 2020, and the Form 483 is dated March 13, 2020.
How do I get the full Form 483 for Air Liquide Canada 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.