Linde Inc
Form 483 issued March 26, 2023 · Pennsylvania
- Investigator
- Luxuly Abraham
- Observations
- 1
- Pages
- 2
- FEI number
- 2523830
In short: On March 26, 2023, FDA issued a Form 483 with 1 observation to Linde Inc in Pennsylvania (FEI 2523830). The investigator was Luxuly Abraham. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no written testing program designed to access the stability characteristic of USP grade (b)…
This inspection in context
Luxuly Abraham
7 documents · 2023–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmLinde Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Linde Inc?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Linde Inc?
Luxuly Abraham is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Linde Inc inspected by FDA?
This Form 483 is dated March 26, 2023.
How do I get the full Form 483 for Linde 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.