Evaric Pharmaceuticals Inc
Form 483 issued May 16, 2025 · Hauppauge, New York
- Inspection
- May 12 – May 16, 2025
- Investigators
- Bijoy Panicker· Luxuly Abraham
- Observations
- 4
- Pages
- 5
- FEI number
- 3013061208
In short: On May 16, 2025, FDA issued a Form 483 with 4 observations to Evaric Pharmaceuticals Inc in Hauppauge, New York (FEI 3013061208) after an inspection that ran May 12 – May 16, 2025. The investigators were Bijoy Panicker and Luxuly Abraham. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
The separate or defined areas and control systems necessary to prevent contamination…
- 04FDCA 582(b)(4)
Your firm failed to have systems in place to enable compliance with the verification…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmEvaric Pharmaceuticals Inc history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Evaric Pharmaceuticals Inc?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Evaric Pharmaceuticals Inc?
Bijoy Panicker and Luxuly Abraham are named on this Form 483, for the inspection of May 12 – May 16, 2025. Each investigator has a profile showing what they cite most.
When was Evaric Pharmaceuticals Inc inspected by FDA?
The inspection ran May 12 – May 16, 2025, and the Form 483 is dated May 16, 2025.
How do I get the full Form 483 for Evaric Pharmaceuticals 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.