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FDA Inspection
•Chartwell Pharmaceuticals LLC•September 19, 2012

Chartwell Pharmaceuticals LLC – FDA Inspection, Sep 19, 2012

Record Details

This FDA Inspection record concerns Chartwell Pharmaceuticals LLC, with an inspection on September 19, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Chartwell Pharmaceuticals LLC
Inspection Date
September 19, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 9c29aa5b-7b08-4a1c-9fad-6cf863085a15

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
799550
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

1
  1. 21 CFR 211.142Written warehousing procedures established/followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Chartwell Pharmaceuticals LLC

8
DateClassificationOfficeProject area
November 18, 2025OAINew York District OfficeDrug Quality Assurance
December 19, 2024Not classifiedNew York District OfficeDrug Quality Assurance
May 31, 2024OAINew York District OfficeGeneric Drug Evaluation
April 8, 2024VAICenter for Drug Evaluation and ResearchBioresearch Monitoring
May 24, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 8 other inspections on the company page
Other documents for Chartwell Pharmaceuticals LLC
  • FDA Inspection 1277530 - 2025-11-18
  • FDA Inspection 1257321 - 2024-12-19
  • FDA Inspection 1236033 - 2024-05-31
  • FDA Inspection 1230475 - 2024-04-08
  • FDA Inspection 1206056 - 2023-05-24

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