FDA Inspection 1209847 — Boston Medical Products, Inc.

Boston Medical Products, Inc. — FEI 3012005554

The FDA completed an inspection of Boston Medical Products, Inc. on July 12, 2023 in Shrewsbury, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 12, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Shrewsbury, MA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures