Evaric Pharmaceuticals Inc
Form 483 issued March 1, 2021 · HAUPPAUGE, New York
- Inspection
- Feb 17 – Mar 1, 2021
- Investigators
- Bijoy Panicker· Brandy N. Lepage
- Observations
- 3
- Pages
- 4
- FEI number
- 3013061208
In short: On March 1, 2021, FDA issued a Form 483 with 3 observations to Evaric Pharmaceuticals Inc in HAUPPAUGE, New York (FEI 3013061208) after an inspection that ran Feb 17 – Mar 1, 2021. The investigators were Bijoy Panicker and Brandy N. Lepage. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 2 of 3 observations.
Most cited: 21 CFR 211.100 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
The batch production and control records are deficient in that they are not an accurate reproduction…
- 03
Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety…
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Evaric Pharmaceuticals Inc?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Evaric Pharmaceuticals Inc?
Bijoy Panicker and Brandy N. Lepage are named on this Form 483, for the inspection of Feb 17 – Mar 1, 2021. Each investigator has a profile showing what they cite most.
When was Evaric Pharmaceuticals Inc inspected by FDA?
The inspection ran Feb 17 – Mar 1, 2021, and the Form 483 is dated March 1, 2021.
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.