# FDA 483 - Chemsil Silicones Inc - October 22, 2024

Source: https://www.keypedia.com/records/483/chemsil-silicones-inc/5d4de8cf-785b-49c0-a367-b91e29511d5c

> FDA 483 for Chemsil Silicones Inc on October 22, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chemsil Silicones Inc
- Inspection Date: 2024-10-22
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Chemsil Silicones Inc, a Class II medical device contract manufacturer in Chatsworth, CA, revealed two significant observations. The firm's procedures for equipment cleaning and maintenance were found to be inadequate, specifically lacking details for rinsing mixing tanks. Additionally, a viscometer used for testing personal lubricant was out of its calibration schedule, indicating a failure in documenting equipment calibrations.

## Related Officers

- [Kelvin Cheung](https://www.keypedia.com/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.keypedia.com/companies/chemsil-silicones-inc/fe37cc7e-a0c3-445b-9743-ece4ac1ed8b7

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7