Brookfield Medical/Surgical Supply, Inc.
Form 483 issued December 21, 2018 · Brookfield, Connecticut
- Inspection
- Dec 10 – Dec 21, 2018
- Investigators
- Erik W. Koester· Robert J. Martin
- Observations
- 8
- Pages
- 6
- FEI number
- 3011430551
In short: On December 21, 2018, FDA issued a Form 483 with 8 observations to Brookfield Medical/Surgical Supply, Inc. in Brookfield, Connecticut (FEI 3011430551) after an inspection that ran Dec 10 – Dec 21, 2018. The investigators were Erik W. Koester and Robert J. Martin. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Each lot of a component that is liable to microbiological contamination that is objectionable in view…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.100(a)
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 8 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Brookfield Medical/Surgical Supply, Inc.?
Erik W. Koester and Robert J. Martin are named on this Form 483, for the inspection of Dec 10 – Dec 21, 2018. Each investigator has a profile showing what they cite most.
When was Brookfield Medical/Surgical Supply, Inc. inspected by FDA?
The inspection ran Dec 10 – Dec 21, 2018, and the Form 483 is dated December 21, 2018.
How do I get the full Form 483 for Brookfield Medical/Surgical Supply, Inc.?
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