# FDA 483 - LEC Custom Products, Inc - September 02, 2022

Source: https://www.keypedia.com/records/483/lec-custom-products-inc/3703f854-0bf3-4aea-b8e2-6e6d428860a9

> FDA 483 for LEC Custom Products, Inc on September 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LEC Custom Products, Inc
- Inspection Date: 2022-09-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: LEC Custom Products, Inc., an OTC drug manufacturer in Mississauga, Ontario, was cited for significant deficiencies across its quality control, production, and labeling operations. The inspection revealed inadequate master production records, failures in deviation management, and issues with equipment qualification and cleaning. Additionally, the firm lacked proper control over labeling and equipment traceability, indicating systemic weaknesses in maintaining cGMP compliance.

## Related Documents

- [WARNING_LETTER - 2020-03-06](https://www.keypedia.com/records/warning_letter/lec-custom-products-inc/86237ae9-69e2-4e57-9c2b-37c8f8270031)

## Related Officers

- [Microbiologist](https://www.keypedia.com/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)

Company: https://www.keypedia.com/companies/lec-custom-products-inc/9abe82c5-54f1-4743-a9eb-5d6ccdead30b

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1