# FDA 483 - SciVac Ltd - March 27, 2023

Source: https://www.keypedia.com/records/483/scivac-ltd/f40a0977-7f5f-4fb5-b686-3104b38fef4f

> FDA 483 for SciVac Ltd on March 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SciVac Ltd
- Inspection Date: 2023-03-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: SciVac LTD, a sterile drug manufacturer in Rehovot, Israel, was cited for significant deficiencies in its aseptic processing controls, personnel training, deviation management, and quality control unit procedures. The inspection revealed issues including inadequate sporicidal agent use, flawed environmental and personnel monitoring, insufficient training for visual inspection, unrecorded deviations, and poor documentation reconciliation practices. These findings indicate a high severity of non-compliance impacting the sterility assurance and overall quality system.

## Related Documents

- [483 - 2023-03-27](https://www.keypedia.com/records/483/scivac-ltd/d11a7d39-21a4-4eb7-b5d5-cb9902919d9c)

## Related Officers

- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/scivac-ltd/8c2211b8-69bf-4d8f-be85-9429be552876

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8