# FDA 483 - MassBiologics - July 13, 2010

Source: https://www.globalkeysolutions.net/records/483/massbiologics/0a149ddf-e774-426d-9cda-94a22372b436

> FDA 483 for MassBiologics on July 13, 2010. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MassBiologics
- Inspection Date: 2010-07-13
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of MassBiologics in Boston, MA, revealed several deficiencies related to quality control and documentation. The firm failed to adequately assess product impact for deviations, properly document visual inspections and product complaint investigations, and maintain complete procedures for environmental monitoring and disinfectant effectiveness. Additionally, media fill summaries and annual product reviews were not approved in a timely manner.

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## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.globalkeysolutions.net/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)

Company: https://www.globalkeysolutions.net/companies/massbiologics/fa584e7c-22de-470c-836a-dd3028fae600

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4