# FDA 483 - North Shore Medical Center - July 02, 2019

Source: https://www.globalkeysolutions.net/records/483/north-shore-medical-center/af631aa6-fe3e-49c8-9c7a-959e4b400312

> FDA 483 for North Shore Medical Center on July 02, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: North Shore Medical Center
- Inspection Date: 2019-07-02
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: The FDA inspected North Shore Medical Center, a blood bank in Salem, MA, and issued a Form 483. The inspection revealed a significant deficiency in the firm's written standard operating procedures concerning the storage and distribution of blood and blood components. Specifically, the facility lacked a procedure for documenting pathologist approval for the emergency use of outdated platelets.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/alice-silva/b4b46db5-2b1a-452c-a403-9265a8785330)

Company: https://www.globalkeysolutions.net/companies/north-shore-medical-center/d7e39195-82cb-445f-928a-abfdd1925d06

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7