Piramal Critical Care Inc
Form 483 issued September 27, 2023 · Bethlehem, Pennsylvania
- Inspection
- Sep 18 – Sep 27, 2023
- Investigator
- Amy N. Chen
- Observations
- 2
- Pages
- 3
- FEI number
- 1000135935
In short: On September 27, 2023, FDA issued a Form 483 with 2 observations to Piramal Critical Care Inc in Bethlehem, Pennsylvania (FEI 1000135935) after an inspection that ran Sep 18 – Sep 27, 2023. The investigator was Amy N. Chen. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67(c) (1×) · 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Records are not kept for…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Amy N. Chen
8 documents · 2022–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Maryland.
The firmPiramal Critical Care Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Piramal Critical Care Inc?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Piramal Critical Care Inc?
Amy N. Chen is named on this Form 483, for the inspection of Sep 18 – Sep 27, 2023. Each investigator has a profile showing what they cite most.
When was Piramal Critical Care Inc inspected by FDA?
The inspection ran Sep 18 – Sep 27, 2023, and the Form 483 is dated September 27, 2023.
How do I get the full Form 483 for Piramal Critical Care 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.