# FDA 483 - Entopsis , Inc. - December 06, 2022

Source: https://www.globalkeysolutions.net/records/483/entopsis-inc/71cb54cf-ddd9-42a3-8e87-e36337d100ef

> FDA 483 for Entopsis , Inc. on December 06, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Entopsis , Inc.
- Inspection Date: 2022-12-06
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Entopsis, Inc. in Medley, FL, revealed significant deficiencies across its quality system. The firm failed to validate critical manufacturing processes, software, and equipment, indicating a broad lack of control over its PCRopsis product production. Additionally, inadequate procedures for acceptance activities, complaint handling, supplier qualification, and document control were observed, highlighting systemic issues in maintaining compliance with regulatory requirements.

## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

Company: https://www.globalkeysolutions.net/companies/entopsis-inc/245f9e09-4ba6-44be-9511-14afc4dfae30

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6