# FDA 483 - Rockline Industries, Inc - May 04, 2018

Source: https://www.keypedia.com/records/483/rockline-industries-inc/47c457de-9b73-4d3a-a9c7-b89367807719

> FDA 483 for Rockline Industries, Inc on May 04, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rockline Industries, Inc
- Inspection Date: 2018-05-04
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Rockline Industries, Inc. in Sheboygan, WI, a manufacturer of OTC, cosmetic, and medical device wet wipes, identified a significant deficiency related to written procedures. The firm lacked adequate procedures for the approval and rejection of components, specifically regarding the assessment of product impact from failures in water used for drug production. This included instances where water conductivity failures were noted without a corresponding product impact assessment.

## Related Officers

- [Performance Improvement Coordinator](https://www.keypedia.com/people/tenzin-jangchup/733eb315-0eeb-40ce-af6d-03b406a9235d)

Company: https://www.keypedia.com/companies/rockline-industries-inc/ff05df6c-f142-4a2f-b75c-5e04d3eea5ee

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d