Tri-Med, Inc. dba Advanced Care Infusion-Shelby
Form 483 issued July 11, 2017 · Clinton Township, Michigan
- Inspection
- Jul 11, 2017
- Investigators
- Bei Y. Ho· Emily J. Orban
- Observations
- 4
- Pages
- 3
- FEI number
- 3011357279
In short: On July 11, 2017, FDA issued a Form 483 with 4 observations to Tri-Med, Inc. dba Advanced Care Infusion-Shelby in Clinton Township, Michigan (FEI 3011357279) after an inspection that ran Jul 11, 2017. The investigators were Bei Y. Ho and Emily J. Orban. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Disinfecting agents and cleaning wipes used in the aseptic processing…
- 02
Personnel engaged in aseptic processing did not use adequate aseptic techniques to ensure…
- 03
Equipment, materials, and/or supplies are not disinfected prior to entering…
- 04
Pressure differentials are not monitored at Jeast daily in areas…
This inspection in context
Bei Y. Ho
1 document · 2017
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
The firmTri-Med, Inc. dba Advanced Care Infusion-Shelby history
All 2 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 Tri-Med, Inc. dba Advanced Care Infusion-Shelby?
FDA listed 4 observations on this Form 483, mostly about production 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 Tri-Med, Inc. dba Advanced Care Infusion-Shelby?
Bei Y. Ho and Emily J. Orban are named on this Form 483, for the inspection of Jul 11, 2017. Each investigator has a profile showing what they cite most.
When was Tri-Med, Inc. dba Advanced Care Infusion-Shelby inspected by FDA?
The inspection ran Jul 11, 2017, and the Form 483 is dated July 11, 2017.
How do I get the full Form 483 for Tri-Med, Inc. dba Advanced Care Infusion-Shelby?
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.