# FDA 483 - Plantex Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/plantex-ltd/0448e4ec-e16f-4a88-b5c6-69790dd9dd64

> FDA 483 for Plantex Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Plantex Ltd.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Plantex Ltd. in Netanya, Israel, revealed significant data integrity and quality control deficiencies. Observations included unauthorized data access and deletion, inadequate test procedures for raw materials and APIs, and insufficient equipment cleaning protocols for microbiological and endotoxin contamination. These issues indicate a lack of robust controls over manufacturing processes and data management.

## Related Officers

- [Investigative Engineer ](https://www.keypedia.com/people/leonard-h-lavi/afe5082f-67e5-4bf2-a981-022756e93eb4)
- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

Company: https://www.keypedia.com/companies/plantex-ltd/b342b402-ec06-447a-ba8b-b95dd61ce90d

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