# FDA 483 - DSC Laboratories, Inc. - July 16, 2025

Source: https://www.keypedia.com/records/483/dsc-laboratories-inc/aadabb2b-6ba7-4a2b-8a26-0c00db68770c

> FDA 483 for DSC Laboratories, Inc. on July 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DSC Laboratories, Inc.
- Inspection Date: 2025-07-16
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: DSC Laboratories, Inc. in Muskegon, MI, an OTC drug manufacturer, was cited for significant deficiencies in quality control and manufacturing practices. The inspection revealed issues including inadequate investigations into microbial contamination in water systems, insufficient water system sampling and stability testing, unqualified laboratory standards, poor computer system controls, and improper drug product storage conditions with unaddressed temperature excursions. These observations indicate a lack of robust quality assurance for their OTC drug products.

## Related Officers

- [Young K. Chou](https://www.keypedia.com/people/young-k-chou/3f34cb70-7f30-453d-9099-885e1b168975)
- [Drug Investigator](https://www.keypedia.com/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)
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Company: https://www.keypedia.com/companies/dsc-laboratories-inc/1cc93494-10c8-4265-8ca4-7761265d1beb

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03