# FDA 483 - Liquipak Corp. - November 01, 2018

Source: https://www.keypedia.com/records/483/liquipak-corp/f5ac8123-9cd2-4b4d-a634-e46546a546a7

> FDA 483 for Liquipak Corp. on November 01, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Liquipak Corp.
- Inspection Date: 2018-11-01
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Liquipak Corp. in Alma, MI, a manufacturer of Tichenor's Toothpaste, revealed two significant observations. The firm's quality control unit failed to follow its own change control procedures by not reviewing and approving a job setup specification. Additionally, the company did not perform routine mechanical equipment inspections according to a written program, specifically lacking documentation for packaging machine validation.

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## Related Officers

- [Bei Y. He](https://www.keypedia.com/people/bei-y-he/6ee057b7-9558-4f4c-b312-9a63821699c2)

Company: https://www.keypedia.com/companies/liquipak-corp/d2b2f45d-157b-4209-bb6b-ba9e7b47c059

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0