Breas Medical, Inc
Form 483 issued January 18, 2022 · North Billerica, Massachusetts
- Inspection
- Jan 11 – Jan 18, 2022
- Investigator
- James P. Finn
- Observations
- 1
- Pages
- 3
- FEI number
- 3010817335
In short: On January 18, 2022, FDA issued a Form 483 with 1 observation to Breas Medical, Inc in North Billerica, Massachusetts (FEI 3010817335) after an inspection that ran Jan 11 – Jan 18, 2022. The investigator was James P. Finn. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures to control environmental conditions…
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 firmBreas Medical, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Breas Medical, Inc?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Breas Medical, Inc?
James P. Finn is named on this Form 483, for the inspection of Jan 11 – Jan 18, 2022. Each investigator has a profile showing what they cite most.
When was Breas Medical, Inc inspected by FDA?
The inspection ran Jan 11 – Jan 18, 2022, and the Form 483 is dated January 18, 2022.
How do I get the full Form 483 for Breas Medical, 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.