# FDA 483 - ApiFix, Ltd. - June 11, 2019

Source: https://www.globalkeysolutions.net/records/483/apifix-ltd/85a97c11-c1f4-4eae-82b3-17d5f5158f4a

> FDA 483 for ApiFix, Ltd. on June 11, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ApiFix, Ltd.
- Inspection Date: 2019-06-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: ApiFix, Ltd. in Holon, Israel, was inspected by the FDA, revealing two significant observations. The inspection found deficiencies in process validation, specifically regarding undefined acceptance criteria for seal strength and bubble leak tests, and inadequately established operating parameters for a machine. Additionally, the firm lacked adequately established procedures for controlling environmental conditions.

## Related Officers

- [Maida Hrenesan](https://www.globalkeysolutions.net/people/maida-hrenesan/79a1e6de-a362-480f-b751-59dd770f776a)
- [Mary A. Millner](https://www.globalkeysolutions.net/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

Company: https://www.globalkeysolutions.net/companies/apifix-ltd/56f5dba2-9a7b-4c73-a78e-60ea775a9508

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