# FDA 483 - MediWound Ltd - November 15, 2022

Source: https://www.keypedia.com/records/483/mediwound-ltd/c470ab8d-9ffb-45fc-b3ef-ac14c4d3d6e5

> FDA 483 for MediWound Ltd on November 15, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MediWound Ltd
- Inspection Date: 2022-11-15
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: MediWound Limited, a drug substance and drug product manufacturer in Yavne, Israel, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate aseptic processing controls, including environmental and personnel monitoring, microbial cross-contamination prevention, and cleaning/sanitization programs. Additionally, the firm's quality oversight, risk assessment for microbial contamination, and qualification of temperature-controlled storage areas were found to be deficient.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/mediwound-ltd/e6430e56-68f9-42a9-8d31-3d55b7debb22)

## Related Officers

- [Esther C. Broner](https://www.keypedia.com/people/esther-c-broner/5df7ca72-a21f-4586-a5e0-8a782045281c)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/andrea-franco/96b35431-a713-48a5-9a47-e160cc650730)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

Company: https://www.keypedia.com/companies/mediwound-ltd/c52a11ba-6190-4ddb-bb89-9b7e75cc10e7

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0