# FDA 483 - Chartwell Pharmaceuticals LLC - September 26, 2018

Source: https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/232c0466-d828-4e9d-98f0-611b166f288d

> FDA 483 for Chartwell Pharmaceuticals LLC on September 26, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Chartwell Pharmaceuticals LLC
- Inspection Date: 2018-09-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: This FDA Form 483 report details observations made during an inspection of Chartwell Pharmaceuticals, LLC in Congers, New York, a pharmaceutical drug manufacturer. The inspection revealed significant deficiencies across multiple areas, including a lack of written procedures for equipment cleaning validation, warehousing, and quality control unit responsibilities, as well as inadequate facility space leading to potential mix-ups and contamination. These issues indicate a general lack of adherence to good manufacturing practices.

## Related Documents

- [EIR - 2016-11-01](https://www.keypedia.com/records/eir/chartwell-pharmaceuticals-llc/10f0c1e9-8bf5-4caf-9779-dad27ca98df7)
- [483 - 2023-05-24](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/de95b640-b564-4faf-9ca2-063958f30e33)
- [483 - 2024-12-19](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/3e48e10b-d9ec-463f-a2bc-238f0af3f5d1)

## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

Company: https://www.keypedia.com/companies/chartwell-pharmaceuticals-llc/4a8c4844-be98-403a-8cb5-5fc90d592679

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961