Chartwell Pharmaceuticals Carmel, LLC
Form 483 issued December 16, 2019 · Carmel, New York
- Inspection
- Dec 3 – Dec 16, 2019
- Investigator
- Mindy M. Chou
- Observations
- 3
- Pages
- 4
- FEI number
- 3009686761
In short: On December 16, 2019, 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 3 – Dec 16, 2019. The investigator was Mindy M. Chou. Most observations concern facilities & equipment.
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
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
- 02
Routine inspection and checking of automatic, mechanical and electronic equipment is not performed according to a…
- 03
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) 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 211.67
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. The opening words of each observation are shown on this page.
Who inspected Chartwell Pharmaceuticals Carmel, LLC?
Mindy M. Chou is named on this Form 483, for the inspection of Dec 3 – Dec 16, 2019. Each investigator has a profile showing what they cite most.
When was Chartwell Pharmaceuticals Carmel, LLC inspected by FDA?
The inspection ran Dec 3 – Dec 16, 2019, and the Form 483 is dated December 16, 2019.
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.