# FDA 483 - Lac Mac Limited - April 17, 2019

Source: https://www.globalkeysolutions.net/records/483/lac-mac-limited/1bcddb20-66cb-409c-9500-7320a756e1b7

> FDA 483 for Lac Mac Limited on April 17, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lac Mac Limited
- Inspection Date: 2019-04-17
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Lac Mac Limited, a medical device manufacturer in London, identified deficiencies in their quality system. Specifically, the firm's procedures for corrective and preventive action were found to be inadequately established. This included issues with inaccurate trending data for non-conformance reports and a lack of a written standard operating procedure for trending and analysis of quality data.

## Related Officers

- [Katelyn A. Staub-Zamperini](https://www.globalkeysolutions.net/people/katelyn-a-staub-zamperini/bb7f95a4-53c1-473c-856e-517312bdba30)

Company: https://www.globalkeysolutions.net/companies/lac-mac-limited/2dcefe1f-ae67-4bc3-bd2f-0fe740cce4bc

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd