Tri-Med, Inc. dba Advanced Care Infusion-Shelby
Form 483 issued February 23, 2015 · Shelby Township, Michigan
- Inspection
- Feb 12 – Feb 23, 2015
- Investigator
- Jeffrey D. Meng
- Observations
- 11
- Pages
- 8
- FEI number
- 3011357279
In short: On February 23, 2015, FDA issued a Form 483 with 11 observations to Tri-Med, Inc. dba Advanced Care Infusion-Shelby in Shelby Township, Michigan (FEI 3011357279) after an inspection that ran Feb 12 – Feb 23, 2015. The investigator was Jeffrey D. Meng. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Jeffrey D. Meng
14 documents · 2010–2016
Cites 211.192 (production record review) 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 211.192
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 11 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. 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 Tri-Med, Inc. dba Advanced Care Infusion-Shelby?
Jeffrey D. Meng is named on this Form 483, for the inspection of Feb 12 – Feb 23, 2015. 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 Feb 12 – Feb 23, 2015, and the Form 483 is dated February 23, 2015.
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.