# FDA 483 - Molecular Products, Ltd. - February 14, 2019

Source: https://www.globalkeysolutions.net/records/483/molecular-products-ltd/778ad96d-8f7a-4b68-bc80-dc402300c541

> FDA 483 for Molecular Products, Ltd. on February 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Molecular Products, Ltd.
- Inspection Date: 2019-02-14
- Product Type: device
- Office Name: Office of Biological Products Operations - Division I
- Summary: Molecular Products, Ltd. in Barlow, Essex, United Kingdom, was inspected from February 11-14, 2019, and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, finished device acceptance procedures, equipment maintenance, and control of non-conforming products. These issues indicate a lack of adequate procedures and timely execution in critical quality control areas.

## Related Officers

- [Tiki Dixon](https://www.globalkeysolutions.net/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.globalkeysolutions.net/companies/molecular-products-ltd/eca97ef5-b379-457b-81c9-54d2d6b92086

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