# FDA 483 - Chartwell Pharmaceuticals Carmel LLC - February 28, 2018

Source: https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-carmel-llc/e2b1e4ee-6b51-46f3-99ec-d77208ad7557

> FDA 483 for Chartwell Pharmaceuticals Carmel LLC on February 28, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chartwell Pharmaceuticals Carmel LLC
- Inspection Date: 2018-02-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Silarx Pharmaceuticals, Inc. in Carmel, NY, a drug product manufacturer, revealed two significant observations. The firm failed to properly handle drug product complaints, specifically neglecting to investigate an adverse reaction report for Loratidine Oral Solution. Additionally, routine equipment checks, including temperature monitoring for critical storage units, were not performed according to a written program on weekends and non-operational days.

## Related Documents

- [EIR - 2019-12-16](https://www.globalkeysolutions.net/records/eir/chartwell-pharmaceuticals-carmel-llc/6db710ba-7d7e-4a95-9db8-28b65aa201e2)
- [483 - 2019-12-16](https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-carmel-llc/8e17e4fb-45af-42a6-8551-1eb58ba205bc)
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## Related Officers

- [Director, Team Biologics Staff](https://www.globalkeysolutions.net/people/helen-b-ricalde/455f022e-4d32-453e-acc7-e84a53ce730c)

Company: https://www.globalkeysolutions.net/companies/chartwell-pharmaceuticals-carmel-llc/7d10681a-1557-4f23-bde4-a9fad718e27f

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