Chartwell Pharmaceuticals Congers, LLC
Form 483 issued May 24, 2023 · Congers, New York
- Inspection
- May 1 – May 24, 2023
- Investigators
- Ankur C. Patel· Robin P. Mathew
- Observations
- 6
- Pages
- 5
- FEI number
- 3008897678
In short: On May 24, 2023, FDA issued a Form 483 with 6 observations to Chartwell Pharmaceuticals Congers, LLC in Congers, New York (FEI 3008897678) after an inspection that ran May 1 – May 24, 2023. The investigators were Ankur C. Patel and Robin P. Mathew. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An adequate number of batches of each drug product are not tested nor are records of…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Employees are not given training in the particular operations they perform as…
- 04
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Ankur C. Patel
9 documents · 2021–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) 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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chartwell Pharmaceuticals Congers, LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Chartwell Pharmaceuticals Congers, LLC?
Ankur C. Patel and Robin P. Mathew are named on this Form 483, for the inspection of May 1 – May 24, 2023. Each investigator has a profile showing what they cite most.
When was Chartwell Pharmaceuticals Congers, LLC inspected by FDA?
The inspection ran May 1 – May 24, 2023, and the Form 483 is dated May 24, 2023.
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.