Brookfield Medical/Surgical Supply, Inc.
Form 483 issued April 9, 2015 · Brookfield, Connecticut
- Inspection
- Mar 30 – Apr 9, 2015
- Investigator
- Maya M. Davis
- Observations
- 9
- Pages
- 9
- FEI number
- 3011430551
In short: On April 9, 2015, FDA issued a Form 483 with 9 observations to Brookfield Medical/Surgical Supply, Inc. in Brookfield, Connecticut (FEI 3011430551) after an inspection that ran Mar 30 – Apr 9, 2015. The investigator was Maya M. Davis. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 6 of 9 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
This inspection in context
Maya M. Davis
4 documents · 2012–2015
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(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 9 observations on this Form 483, mostly about production, quality system 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.?
Maya M. Davis is named on this Form 483, for the inspection of Mar 30 – Apr 9, 2015. Each investigator has a profile showing what they cite most.
When was Brookfield Medical/Surgical Supply, Inc. inspected by FDA?
The inspection ran Mar 30 – Apr 9, 2015, and the Form 483 is dated April 9, 2015.
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.