Air Liquide Healthcare America Corporation
Form 483 issued May 26, 2015 · Plumsteadville, Pennsylvania
- Inspection
- May 26, 2015
- Investigator
- Luis A. Dasta
- Observations
- 1
- Pages
- 1
- FEI number
- 2518435
In short: On May 26, 2015, FDA issued a Form 483 with 1 observation to Air Liquide Healthcare America Corporation in Plumsteadville, Pennsylvania (FEI 2518435) after an inspection that ran May 26, 2015. The investigator was Luis A. Dasta. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Out of specification investigations…
This inspection in context
Luis A. Dasta
2 documents · 2015
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in India.
The firmAir Liquide Healthcare America Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Air Liquide Healthcare America Corporation?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Air Liquide Healthcare America Corporation?
Luis A. Dasta is named on this Form 483, for the inspection of May 26, 2015. Each investigator has a profile showing what they cite most.
When was Air Liquide Healthcare America Corporation inspected by FDA?
The inspection ran May 26, 2015, and the Form 483 is dated May 26, 2015.
How do I get the full Form 483 for Air Liquide Healthcare America Corporation?
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.