# FDA 483 - Cetylite Industries, Inc. - December 09, 2024

Source: https://www.keypedia.com/records/483/cetylite-industries-inc/e60502e0-36be-4201-a8c2-97463d5fb8b9

> FDA 483 for Cetylite Industries, Inc. on December 09, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cetylite Industries, Inc.
- Inspection Date: 2024-12-09
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Cetylite Industries, Inc. in Pennsauken, NJ, was cited for significant deficiencies in their manufacturing processes and quality control during an FDA inspection. Observations included inadequate process and cleaning validations, and a failure to thoroughly investigate repeated microbial contamination in their purified water system. These issues indicate a lack of robust controls to assure drug product quality and purity.

## 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)
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- [483 - 2025-04-07](https://www.keypedia.com/records/483/cetylite-industries-inc/00452860-ebf9-475e-a732-7948334e0552)

## Related Officers

- [Rahi D. Patel](https://www.keypedia.com/people/rahi-d-patel/aa11c863-2b54-4b1d-afe4-fd8fa715faee)
- [Investigator ](https://www.keypedia.com/people/juanita-p-versace/dca6c7fb-62ac-4b06-9c77-dbf52fc83422)

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