# FDA 483 - Cetylite Industries, Inc. - December 20, 2019

Source: https://www.keypedia.com/records/483/cetylite-industries-inc/4d4c3ed5-52c5-483d-81e8-d6f9dc3d9fc9

> FDA 483 for Cetylite Industries, Inc. on December 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cetylite Industries, Inc.
- Inspection Date: 2019-12-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Cetylite Industries, Inc. in Pennsauken, NJ, a pharmaceutical manufacturer, revealed significant deficiencies in quality management and product control. The firm was cited for inadequate qualified personnel in its Quality Assurance and Quality Control units, leading to uncompleted manufacturing process validations and overdue Annual Product Reviews. Additionally, the quality and safety of the compressed gas propellant used in their aerosol topical anesthetic spray were unknown, and the product lacked an approved marketing application.

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## Related Officers

- [Russell J. Glapion](https://www.keypedia.com/people/russell-j-glapion/54dd6274-563a-44fe-8016-2ebd700be7a0)

Company: https://www.keypedia.com/companies/cetylite-industries-inc/750fff5e-267e-48ab-9e37-75b98e70cea3

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