# FDA 483 - Weeks & Leo Co Inc - March 29, 2018

Source: https://www.keypedia.com/records/483/weeks-leo-co-inc/053fd3e3-a4e1-4aea-965d-f712c7bb8c02

> FDA 483 for Weeks & Leo Co Inc on March 29, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Weeks & Leo Co Inc
- Inspection Date: 2018-03-29
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Weeks & Leo Co Inc was cited for significant deficiencies in their manufacturing processes for dietary supplements. Observations included inadequate cleaning validations, lack of established specifications for incoming materials, and multiple failures in Master Manufacturing Records and Batch Production Records regarding controls, procedures, sampling, labeling, and record-keeping. Additionally, the firm lacked effective measures to prevent foreign material contamination, evidenced by a past complaint involving a metal screw.

## Related Documents

- [483 - 2022-04-07](https://www.keypedia.com/records/483/weeks-leo-co-inc/d25e22a1-a433-4adb-a8bd-25fcc32dae43)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.keypedia.com/companies/weeks-leo-co-inc/905c990f-85e2-4a87-bc5a-ccc027107a97

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8