Chartwell Pharmaceuticals Congers, LLC
Form 483 issued September 26, 2018 · Congers, New York
- Inspection
- Sep 12 – Sep 26, 2018
- Investigator
- Sony Mathews
- Observations
- 4
- Pages
- 3
- FEI number
- 3008897678
In short: On September 26, 2018, FDA issued a Form 483 with 4 observations to Chartwell Pharmaceuticals Congers, LLC in Congers, New York (FEI 3008897678) after an inspection that ran Sep 12 – Sep 26, 2018. The investigator was Sony Mathews. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Procedures describing the warehousing of drug…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix…
This inspection in context
Sony Mathews
22 documents · 2010–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chartwell Pharmaceuticals Congers, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials and quality system. The opening words of each observation are shown on this page.
Who inspected Chartwell Pharmaceuticals Congers, LLC?
Sony Mathews is named on this Form 483, for the inspection of Sep 12 – Sep 26, 2018. Each investigator has a profile showing what they cite most.
When was Chartwell Pharmaceuticals Congers, LLC inspected by FDA?
The inspection ran Sep 12 – Sep 26, 2018, and the Form 483 is dated September 26, 2018.
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.