Boston Brace International Inc
Form 483 issued June 29, 2023 · Avon, Massachusetts
- Inspection
- Jun 22 – Jun 29, 2023
- Investigator
- James P. Finn
- Observations
- 9
- Pages
- 8
- FEI number
- 3001967835
In short: On June 29, 2023, FDA issued a Form 483 with 9 observations to Boston Brace International Inc in Avon, Massachusetts (FEI 3001967835) after an inspection that ran Jun 22 – Jun 29, 2023. The investigator was James P. Finn. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for collective and preventive action have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Procediues have not been adequately established to control product that does not…
- 04
Acceptance activities were not…
This inspection in context
James P. Finn
10 documents · 2019–2026
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Massachusetts.
The firmBoston Brace International Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boston Brace International Inc?
FDA listed 9 observations on this Form 483, mostly about cAPA, management controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected Boston Brace International Inc?
James P. Finn is named on this Form 483, for the inspection of Jun 22 – Jun 29, 2023. Each investigator has a profile showing what they cite most.
When was Boston Brace International Inc inspected by FDA?
The inspection ran Jun 22 – Jun 29, 2023, and the Form 483 is dated June 29, 2023.
How do I get the full Form 483 for Boston Brace International Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.