Chartwell Pharmaceuticals Carmel, LLC
Form 483 issued January 11, 2024 · Carmel, New York
- Inspection
- Jan 4 – Jan 11, 2024
- Observations
- 3
- Pages
- 4
- FEI number
- 3009686761
In short: On January 11, 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 Jan 4 – Jan 11, 2024. Most observations concern facilities & equipment and production.
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
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
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 production. The opening words of each observation are shown on this page.
When was Chartwell Pharmaceuticals Carmel, LLC inspected by FDA?
The inspection ran Jan 4 – Jan 11, 2024, and the Form 483 is dated January 11, 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.