Brookfield Medical/Surgical Supply, Inc.
Form 483 issued April 18, 2017 · Brookfield, Connecticut
- Inspection
- Apr 6 – Apr 18, 2017
- Investigators
- Christopher Janik· Nealie C. Newberger
- Observations
- 4
- Pages
- 4
- FEI number
- 3011430551
In short: On April 18, 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 Apr 6 – Apr 18, 2017. The investigators were Christopher Janik and Nealie C. Newberger. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any llllexplained discrepancy and the failure of a batch…
- 02
Aseptic processing areas are deficient regarding the system for cleaning an d disinfecting the room and…
- 03
Procedures designed to prevent microbiological contamination of dmg products pmp orting to be sterile are not…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Christopher Janik
2 documents · 2017
Cites 211.42 (design and construction features) 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 211.192
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 4 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Brookfield Medical/Surgical Supply, Inc.?
Christopher Janik and Nealie C. Newberger are named on this Form 483, for the inspection of Apr 6 – Apr 18, 2017. Each investigator has a profile showing what they cite most.
When was Brookfield Medical/Surgical Supply, Inc. inspected by FDA?
The inspection ran Apr 6 – Apr 18, 2017, and the Form 483 is dated April 18, 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.