Brookfield Medical/Surgical Supply, Inc.
Form 483 issued June 28, 2017 · Brookfield, Connecticut
- Inspection
- Jun 20 – Jun 28, 2017
- Investigators
- Dien N. Nguyen· Nealie C. Newberger
- Observations
- 4
- Pages
- 2
- FEI number
- 3011430551
In short: On June 28, 2017, FDA issued a Form 483 with 4 observations to Brookfield Medical/Surgical Supply, Inc. in Brookfield, Connecticut (FEI 3011430551) after an inspection that ran Jun 20 – Jun 28, 2017. The investigators were Dien N. Nguyen and Nealie C. Newberger. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and materials account for 3 of 4 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your finn produces drug products intended for intrathecal \!Se from non-sterile bulk active ingredients that are…
- 02
The use of sporicidal agents in the cleanrooms and ISO…
- 03
ISO-5 classified areas were not…
- 04
The ISO classified areas have difficult to clean, particle-generating, or visibly…
This inspection in context
Dien N. Nguyen
6 documents · 2016–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Connecticut.
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
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, materials and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Brookfield Medical/Surgical Supply, Inc.?
Dien N. Nguyen and Nealie C. Newberger are named on this Form 483, for the inspection of Jun 20 – Jun 28, 2017. Each investigator has a profile showing what they cite most.
When was Brookfield Medical/Surgical Supply, Inc. inspected by FDA?
The inspection ran Jun 20 – Jun 28, 2017, and the Form 483 is dated June 28, 2017.
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.