Brookfield Medical/Surgical Supply, Inc.
Form 483 issued July 10, 2026 · Brookfield, Connecticut
- Inspection
- Jun 29 – Jul 10, 2026
- Investigator
- Sangeeta M. Khurana
- Observations
- 3
- Pages
- 7
- FEI number
- 3011430551
In short: On July 10, 2026, FDA issued a Form 483 with 3 observations to Brookfield Medical/Surgical Supply, Inc. in Brookfield, Connecticut (FEI 3011430551) after an inspection that ran Jun 29 – Jul 10, 2026. The investigator was Sangeeta M. Khurana. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Sangeeta M. Khurana
20 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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 211.192
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 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Brookfield Medical/Surgical Supply, Inc.?
Sangeeta M. Khurana is named on this Form 483, for the inspection of Jun 29 – Jul 10, 2026. Each investigator has a profile showing what they cite most.
When was Brookfield Medical/Surgical Supply, Inc. inspected by FDA?
The inspection ran Jun 29 – Jul 10, 2026, and the Form 483 is dated July 10, 2026.
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.