Tri-Med, Inc. dba Advanced Care Infusion-Shelby
FDA inspection history across 2 sites, 2015 to 2017
- 2
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17Two Form 483s, at Shelby Township, Michigan and Clinton Township, Michigan.
- 2015The longest 483 on file: 11 observations over 8 pages at Shelby Township, Michigan.
Cited most
Across all Tri-Med, Inc. dba Advanced Care Infusion-Shelby observations on file
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.167(a)Special testing requirements1
The complete Tri-Med, Inc. dba Advanced Care Infusion-Shelby file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Clinton Township, Michigan
One Form 483 · 2017 · 4 observations
Latest: Form 483, Jul 11, 2017 →Shelby Township, Michigan
One Form 483 · 2015 · 11 observations
Latest: Form 483, Feb 23, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-07-11 | 483 Form 483 | Clinton Township, Michigan | 4 | $99 |
| 2015-02-23 | 483 Form 483 | Shelby Township, Michigan | 11 | $99 |
Investigators on these documents
FEI number 3011357279 · most recent document Jul 11, 2017
About Tri-Med, Inc. dba Advanced Care Infusion-Shelby
How many FDA Form 483s has Tri-Med, Inc. dba Advanced Care Infusion-Shelby received?
FDA Intel has 2 Form 483s on file for Tri-Med, Inc. dba Advanced Care Infusion-Shelby; the most recent is dated Jul 11, 2017.
When was Tri-Med, Inc. dba Advanced Care Infusion-Shelby last inspected by FDA?
The most recent FDA inspection document on file for Tri-Med, Inc. dba Advanced Care Infusion-Shelby is a Form 483 dated Jul 11, 2017, for the site in Clinton Township, Michigan.
What did FDA cite at Tri-Med, Inc. dba Advanced Care Infusion-Shelby?
The regulations cited most in the observations on file for Tri-Med, Inc. dba Advanced Care Infusion-Shelby are 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.165(a) (Testing and release for distribution), 1 time.