# FDA 483 - Molecular Biologicals, LLC - September 26, 2019

Source: https://www.globalkeysolutions.net/records/483/molecular-biologicals-llc/8ad422b5-92bc-422b-a627-d1414e6875f4

> FDA 483 for Molecular Biologicals, LLC on September 26, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Molecular Biologicals, LLC
- Inspection Date: 2019-09-26
- Product Type: device
- Office Name: Dallas District Office
- Summary: Molecular Biologicals, LLC, an initial importer in Pasadena, TX, was cited for multiple significant quality system deficiencies during an FDA inspection from September 10-26, 2019. The firm lacked established written procedures for medical device reporting, complaint handling, corrective and preventive actions, control and distribution of finished devices, and acceptance of incoming products. These observations indicate a fundamental absence of critical quality system controls.

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/molecular-biologicals-llc/7023d95e-b8ed-416b-9989-d05c4d92760d

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9