Brookfield Medical/Surgical Supply, Inc.
Form 483 issued May 10, 2024 · Brookfield, Connecticut
- Inspection
- Apr 22 – May 10, 2024
- Investigators
- Armen H. Youssoufian· Jonathan G. Matrisciano· Ogechi C. Nna
- Observations
- 4
- Pages
- 5
- FEI number
- 3011430551
In short: On May 10, 2024, FDA issued a Form 483 with 4 observations to Brookfield Medical/Surgical Supply, Inc. in Brookfield, Connecticut (FEI 3011430551) after an inspection that ran Apr 22 – May 10, 2024. The investigators were Armen H. Youssoufian, Jonathan G. Matrisciano and Ogechi C. Nna. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Your fnm failed to establish adequate written procedures for production and process controls designed to assure…
- 04FDCA 503B(a)(10)(B)
Observation 4: scanned text, readable in the full document.
This inspection in context
Armen H. Youssoufian
9 documents · 2023–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
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 211.113(b)
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 4 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Brookfield Medical/Surgical Supply, Inc.?
Armen H. Youssoufian, Jonathan G. Matrisciano and Ogechi C. Nna are named on this Form 483, for the inspection of Apr 22 – May 10, 2024. Each investigator has a profile showing what they cite most.
When was Brookfield Medical/Surgical Supply, Inc. inspected by FDA?
The inspection ran Apr 22 – May 10, 2024, and the Form 483 is dated May 10, 2024.
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.