Chartwell Pharmaceuticals Carmel, LLC
Form 483 issued December 20, 2024 · Carmel, New York
- Inspection
- Dec 16 – Dec 20, 2024
- Investigator
- Andrew O. Ejiofor
- Observations
- 3
- Pages
- 4
- FEI number
- 3009686761
In short: On December 20, 2024, FDA issued a Form 483 with 3 observations to Chartwell Pharmaceuticals Carmel, LLC in Carmel, New York (FEI 3009686761) after an inspection that ran Dec 16 – Dec 20, 2024. The investigator was Andrew O. Ejiofor. Most observations concern facilities & equipment and laboratory controls.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Andrew O. Ejiofor
5 documents · 2024–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Georgia.
The firmChartwell Pharmaceuticals Carmel, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.176
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chartwell Pharmaceuticals Carmel, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Chartwell Pharmaceuticals Carmel, LLC?
Andrew O. Ejiofor is named on this Form 483, for the inspection of Dec 16 – Dec 20, 2024. Each investigator has a profile showing what they cite most.
When was Chartwell Pharmaceuticals Carmel, LLC inspected by FDA?
The inspection ran Dec 16 – Dec 20, 2024, and the Form 483 is dated December 20, 2024.
How do I get the full Form 483 for Chartwell Pharmaceuticals Carmel, 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.