# FDA 483 - ApiFix, Ltd. - June 06, 2019

Source: https://www.globalkeysolutions.net/records/483/apifix-ltd/b6cd6869-fbea-4f6e-9253-94865dc44da8

> FDA 483 for ApiFix, Ltd. on June 06, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ApiFix, Ltd.
- Inspection Date: 2019-06-06
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: ApiFix, Ltd., a medical device manufacturer in Misgav, Israel, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies in their quality system, particularly concerning complaint handling, corrective and preventive actions, process validation, design change control, acceptance activities, and employee training. These issues indicate a lack of robust controls over critical aspects of device manufacturing and quality management.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/maida-henesian/cd28e878-000c-4af8-8dbd-4863057758bb)
- [Mary A. Millner](https://www.globalkeysolutions.net/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

Company: https://www.globalkeysolutions.net/companies/apifix-ltd/a35c688f-6f82-4168-95bd-811b16763d78

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