# FDA 483 - Quagen Pharma, LLC - March 15, 2019

Source: https://www.globalkeysolutions.net/records/483/quagen-pharma-llc/bdb7744a-7068-46c2-9d56-752a455d041b

> FDA 483 for Quagen Pharma, LLC on March 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quagen Pharma, LLC
- Inspection Date: 2019-03-15
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Quagen Pharma, LLC, a drug manufacturer in West Caldwell, NJ, was cited for failing to follow written procedures for the cleaning and maintenance of equipment. Inspectors observed extensive product residue on a tube filling machine that was labeled as "cleaned," indicating a significant deviation from established protocols and potential impact on drug product quality.

## Related Documents

- [483 - 2019-11-08](https://www.globalkeysolutions.net/records/483/quagen-pharma-llc/69acecaa-79d7-4f23-a6f5-9cde9c82fa62)
- [483 - 2020-10-26](https://www.globalkeysolutions.net/records/483/quagen-pharma-llc/55d3e58f-df6e-4ed1-b054-d5a36a188d34)

## Related Officers

- [Yvesna Blaise](https://www.globalkeysolutions.net/people/yvesna-blaise/4cd6b7c2-78a7-490d-9354-52046bc7344f)
- [investigator](https://www.globalkeysolutions.net/people/monika-borkowska/4dedee7d-7b93-4f1b-be3b-17ab41e5c0ff)

Company: https://www.globalkeysolutions.net/companies/quagen-pharma-llc/cd9437ab-54e0-430e-a568-3835f717bdf1

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248