# FDA 483 - SciVac Ltd - March 27, 2023

Source: https://www.keypedia.com/records/483/scivac-ltd/8b4198a4-9ca4-4cce-b56e-7f4d55f5f17c

> 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: FDA District Office — Silver Springs, Maryland
- Summary: An FDA inspection of SciVac LTD, a sterile drug manufacturer in Rehovot, Israel, revealed significant deficiencies across multiple areas. Observations included inadequate procedures to prevent microbiological contamination, insufficient employee training, failures in recording and justifying deviations, and a quality control unit that did not fully follow its own written procedures. These issues collectively indicate a serious lack of control over sterile drug manufacturing processes.

## Related Documents

- [483 - 2023-03-27](https://www.keypedia.com/records/483/scivac-ltd/f40a0977-7f5f-4fb5-b686-3104b38fef4f)
- [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/fda-district-office-silver-springs-maryland/88352440-432a-426b-ad8b-f768d4460a19