Ascent Pharmaceuticals Inc
Form 483 issued October 13, 2020 · Central Islip, New York
- Inspection
- Sep 17 – Oct 13, 2020
- Investigator
- Bijoy Panicker
- Observations
- 4
- Pages
- 6
- FEI number
- 3009518416
In short: On October 13, 2020, FDA issued a Form 483 with 4 observations to Ascent Pharmaceuticals Inc in Central Islip, New York (FEI 3009518416) after an inspection that ran Sep 17 – Oct 13, 2020. The investigator was Bijoy Panicker. Most observations concern facilities & equipment and production.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Written production and process control procedures are not followed in the execution of production…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Drug products are not stored under appropriate conditions of humidity s o that their identity, strength…
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 firmAscent Pharmaceuticals Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ascent Pharmaceuticals Inc?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Ascent Pharmaceuticals Inc?
Bijoy Panicker is named on this Form 483, for the inspection of Sep 17 – Oct 13, 2020. Each investigator has a profile showing what they cite most.
When was Ascent Pharmaceuticals Inc inspected by FDA?
The inspection ran Sep 17 – Oct 13, 2020, and the Form 483 is dated October 13, 2020.
How do I get the full Form 483 for Ascent 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.