Chartwell Pharmaceuticals Congers, LLC
Form 483 issued December 19, 2024 · Congers, New York
- Inspection
- Dec 9 – Dec 19, 2024
- Investigators
- Alisha B. Patel· Josh Renzo N. Ramilo
- Observations
- 5
- Pages
- 11
- FEI number
- 3008897678
In short: On December 19, 2024, FDA issued a Form 483 with 5 observations to Chartwell Pharmaceuticals Congers, LLC in Congers, New York (FEI 3008897678) after an inspection that ran Dec 9 – Dec 19, 2024. The investigators were Alisha B. Patel and Josh Renzo N. Ramilo. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Alisha B. Patel
2 documents · 2024
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmChartwell Pharmaceuticals Congers, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chartwell Pharmaceuticals Congers, LLC?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Chartwell Pharmaceuticals Congers, LLC?
Alisha B. Patel and Josh Renzo N. Ramilo are named on this Form 483, for the inspection of Dec 9 – Dec 19, 2024. Each investigator has a profile showing what they cite most.
When was Chartwell Pharmaceuticals Congers, LLC inspected by FDA?
The inspection ran Dec 9 – Dec 19, 2024, and the Form 483 is dated December 19, 2024.
How do I get the full Form 483 for Chartwell Pharmaceuticals Congers, LLC?
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.