Brookfield Medical/Surgical Supply, Inc.
Form 483 issued April 4, 2022 · Brookfield, Connecticut
- Inspection
- Mar 21 – Apr 4, 2022
- Investigators
- Erik W. Koester· Jonah S. Ufferfilge
- Observations
- 5
- Pages
- 5
- FEI number
- 3011430551
In short: On April 4, 2022, FDA issued a Form 483 with 5 observations to Brookfield Medical/Surgical Supply, Inc. in Brookfield, Connecticut (FEI 3011430551) after an inspection that ran Mar 21 – Apr 4, 2022. The investigators were Erik W. Koester and Jonah S. Ufferfilge. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacturing, processing and holding of a dmg product are not maintained in…
- 02
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
The calibration of instruments is not done at suitable intervals in accordance with…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmBrookfield Medical/Surgical Supply, Inc. history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Brookfield Medical/Surgical Supply, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Brookfield Medical/Surgical Supply, Inc.?
Erik W. Koester and Jonah S. Ufferfilge are named on this Form 483, for the inspection of Mar 21 – Apr 4, 2022. Each investigator has a profile showing what they cite most.
When was Brookfield Medical/Surgical Supply, Inc. inspected by FDA?
The inspection ran Mar 21 – Apr 4, 2022, and the Form 483 is dated April 4, 2022.
How do I get the full Form 483 for Brookfield Medical/Surgical Supply, 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.