# FDA 483 - Encore Scientific LLC - June 13, 2019

Source: https://www.globalkeysolutions.net/records/483/encore-scientific-llc/8e6ff751-86bc-4a80-85ec-bc6dbe639aa4

> FDA 483 for Encore Scientific LLC on June 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Encore Scientific LLC
- Inspection Date: 2019-06-13
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Encore Scientific LLC, an API re-packager in Broken Arrow, OK, revealed significant deficiencies in their quality control unit, record-keeping practices, and overall adherence to Good Manufacturing Practices. The firm failed to establish adequate written procedures for critical operations, ensure proper review and approval of batch records, and maintain appropriate controls over computer systems and equipment calibration. These issues indicate a systemic lack of control over their re-packaging and distribution processes.

## Related Officers

- [Strategic Accounts Operations Manager / Account Executive](https://www.globalkeysolutions.net/people/aqualia-l-nelson/8ceeb15a-29d4-4924-aca0-0a7c86761a82)
- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.globalkeysolutions.net/companies/encore-scientific-llc/819c1380-8636-4587-8e36-b8dc8006eb83

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