# FDA 483 - Bio-Technology General (Israel), Ltd. - March 16, 2023

Source: https://www.keypedia.com/records/483/bio-technology-general-israel-ltd/f1a4f9b5-347c-497b-bfae-618426631fa7

> FDA 483 for Bio-Technology General (Israel), Ltd. on March 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio-Technology General (Israel), Ltd.
- Inspection Date: 2023-03-16
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Bio-Technology General (Israel) Ltd (BTG) in Kiryat Malachi revealed significant deficiencies in their drug substance manufacturing. The firm experienced widespread microbial contamination, inadequate process controls for viral and microbial safety, and ineffective cleaning procedures. Additionally, issues were noted with facility design, equipment maintenance, documentation, investigations, and the effectiveness of corrective actions, indicating a lack of robust quality control.

## Related Officers

- [Lei Zhang, Ph.D., Lead Biologist](https://www.keypedia.com/people/lei-zhang-phd-lead-biologist/4bd40e48-32c6-46fc-a4b9-80523adb937f)
- [Qiong Fu, Ph.D., Investigator](https://www.keypedia.com/people/qiong-fu-phd-investigator/563c5cbc-6c58-49b9-a3b3-7fd0d6d65fe5)
- [Robert J. Ham, S., Consumer Safety Officer](https://www.keypedia.com/people/robert-j-ham-s-consumer-safety-officer/a0d9978d-f948-49d4-ae4b-b3a580d57066)
- [Madushani Dharmasema, Ph.D., Senior Pharmaceutical](https://www.keypedia.com/people/madushani-dharmasema-phd-senior-pharmaceutical/e1658b6a-883a-4386-9a9a-415e225c4e2c)

Company: https://www.keypedia.com/companies/bio-technology-general-israel-ltd/7e4f2eb9-bacb-4307-9003-5a223c16eed8

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