# FDA 483 - Dyno Manufacturing, Inc - November 01, 2024

Source: https://www.globalkeysolutions.net/records/483/dyno-manufacturing-inc/95156dab-9a55-4f19-8c29-4a6a6c8b7005

> FDA 483 for Dyno Manufacturing, Inc on November 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dyno Manufacturing, Inc
- Inspection Date: 2024-11-01
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Dyno Manufacturing Inc. in Madison, IL, revealed significant deficiencies in the manufacturing of liquid OTC hand sanitizer and antibacterial soap drug products. The firm lacked an approved stability testing program and had not conducted stability studies to support product expiration dates. Additionally, the inspection found failures in establishing written procedures for production and process controls, including incomplete process validation and equipment qualifications, and issues with the quality control unit's responsibilities, such as self-review of test results and uncompleted annual product reviews.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/mary-l-schuckmann/fdbfffff-ef4b-49a2-8ea3-6254a600aaac)

Company: https://www.globalkeysolutions.net/companies/dyno-manufacturing-inc/6eb85a1a-4fdb-4094-b99d-72c4363149b7

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669