# FDA 483 - Luster Products Inc - September 13, 2024

Source: https://www.globalkeysolutions.net/records/483/luster-products-inc/3e3644c7-8daa-47d5-89df-b587da88cf21

> FDA 483 for Luster Products Inc on September 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Luster Products Inc
- Inspection Date: 2024-09-13
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Luster Products Inc, an OTC drug and cosmetic manufacturer in Chicago, was cited with five observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality system, including a lack of a comprehensive stability testing program for hand sanitizers, inadequate laboratory controls for release testing, and failure to perform identity testing on critical components. Additionally, the quality control unit's responsibilities were not fully documented or followed, and employees lacked essential CGMP training.

## Related Officers

- [Travis V. Hull](https://www.globalkeysolutions.net/people/travis-v-hull/1f3b5843-29ed-4291-8a8a-a2bf3ac36988)
- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.globalkeysolutions.net/companies/luster-products-inc/6ba65506-6815-44d2-b4f8-dcdc9a7290ea

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