# FDA 483 - Cetylite Industries, Inc. - September 24, 2021

Source: https://www.keypedia.com/records/483/cetylite-industries-inc/0df372df-3ee9-4f01-805e-444064742927

> FDA 483 for Cetylite Industries, Inc. on September 24, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cetylite Industries, Inc.
- Inspection Date: 2021-09-24
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Cetylite Industries, Inc. in Pennsauken, NJ, a pharmaceutical manufacturer, was cited for two significant issues during an FDA inspection. The firm lacked data to support the safety of the propellant used in its Topical Anesthetic Spray and failed to thoroughly investigate out-of-specification results for a Topical Anesthetic Gel batch before release. These observations indicate serious deficiencies in laboratory controls and quality assurance processes.

## Related Documents

- [483 - 2019-12-20](https://www.keypedia.com/records/483/cetylite-industries-inc/4d4c3ed5-52c5-483d-81e8-d6f9dc3d9fc9)
- [WARNING_LETTER - 2021-09-24](https://www.keypedia.com/records/warning_letter/cetylite-industries-inc/2853f146-444d-4046-b2ac-947cef10136a)
- [483 - 2023-03-02](https://www.keypedia.com/records/483/cetylite-industries-inc/58018783-a63d-4196-a213-10aed4198d59)
- [483 - 2024-12-09](https://www.keypedia.com/records/483/cetylite-industries-inc/e60502e0-36be-4201-a8c2-97463d5fb8b9)
- [483 - 2025-04-07](https://www.keypedia.com/records/483/cetylite-industries-inc/00452860-ebf9-475e-a732-7948334e0552)

## 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