# FDA 483 - Boston Medical Products, Inc. - July 12, 2023

Source: https://www.globalkeysolutions.net/records/483/boston-medical-products-inc/3eb883c3-4e57-4c56-a540-2802f6a2000a

> FDA 483 for Boston Medical Products, Inc. on July 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boston Medical Products, Inc.
- Inspection Date: 2023-07-12
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Boston Medical Products, Inc., a distributor in Shrewsbury, MA, revealed a significant procedural deficiency. The firm failed to develop written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences for its approved drug product, Steritalc. This indicates a lack of essential controls for drug safety reporting.

## Related Officers

- [Betsy C. Galliher](https://www.globalkeysolutions.net/people/betsy-c-galliher/04add63c-cbcb-42f7-b634-7c2925600bef)

Company: https://www.globalkeysolutions.net/companies/boston-medical-products-inc/d1e78054-f4e8-48e6-98eb-b25d80158e38

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