# FDA 483 - Cetylite Industries, Inc. - April 07, 2025

Source: https://www.keypedia.com/records/483/cetylite-industries-inc/00452860-ebf9-475e-a732-7948334e0552

> FDA 483 for Cetylite Industries, Inc. on April 07, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Cetylite Industries, Inc.
- Inspection Date: 2025-04-07
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Cetylite Industries, Inc. in Pennsauken, NJ, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for internal quality audits and did not adhere to their own written procedures for supplier qualification and re-evaluation. These issues indicate a lack of robust quality management practices.

## Related Documents

- [483 - 2019-12-20](https://www.keypedia.com/records/483/cetylite-industries-inc/4d4c3ed5-52c5-483d-81e8-d6f9dc3d9fc9)
- [483 - 2021-09-24](https://www.keypedia.com/records/483/cetylite-industries-inc/0df372df-3ee9-4f01-805e-444064742927)
- [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)

## Related Officers

- [Shirley S. Wen](https://www.keypedia.com/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)

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