Chartwell Pharmaceuticals Carmel, LLC
Form 483 issued October 6, 2022 · Carmel, New York
- Inspection
- Sep 28 – Oct 6, 2022
- Investigators
- Bijoy Panicker· Brandy N. Lepage
- Observations
- 6
- Pages
- 6
- FEI number
- 3009686761
In short: On October 6, 2022, FDA issued a Form 483 with 6 observations to Chartwell Pharmaceuticals Carmel, LLC in Carmel, New York (FEI 3009686761) after an inspection that ran Sep 28 – Oct 6, 2022. The investigators were Bijoy Panicker and Brandy N. Lepage. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not reviewed and approved by…
- 02
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
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 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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chartwell Pharmaceuticals Carmel, LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and materials. The opening words of each observation are shown on this page.
Who inspected Chartwell Pharmaceuticals Carmel, LLC?
Bijoy Panicker and Brandy N. Lepage are named on this Form 483, for the inspection of Sep 28 – Oct 6, 2022. Each investigator has a profile showing what they cite most.
When was Chartwell Pharmaceuticals Carmel, LLC inspected by FDA?
The inspection ran Sep 28 – Oct 6, 2022, and the Form 483 is dated October 6, 2022.
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.