care research, llc€¦ · conducted aug 9 th – 15 th, 2012 no deficiencies found no 483 issued...

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CARE RESEARCH, LLC

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Page 1: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

CARE RESEARCH, LLC

Page 2: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

22 Acre Facility, Northern Colorado

Page 3: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Conducted Aug 9 th – 15 th, 2012

No deficiencies found

No 483 Issued

Compliments on Documentation & Procedures

Recent FDA Audit

Page 4: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Main Building, Surgery (large animals), small animal

facility

Page 5: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Certifications

•USDA

•OLAW

•EU ETS123

Page 6: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Outdoor Pastures - Large Farm Animals, Equine to

Swine

Page 7: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Indoor Facilities - Large Swine &

Poultry

Page 8: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

In-House Clinical Services

•Hematology, Clinical Chemistry

•Complete, detailed Histopathology

Modern, fully equipped veterinary surgical

suite with C-ARM

Page 9: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Metabolism & Special PK/TK, Including BBB with

CSF & Infused Brain Collection

Page 10: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Small Animal:

Mice, rats, ferrets,

rabbits, hamsters,

guinea pigs

•Acute to chronic tox.

•Pharmacokinetic/Toxico

-kinetic models

•Reproductive/developm

ental toxicology

•Special models

(arthritis, respiratory, in-

vivo biocompatibility)

Species of Focus

(GLP & non-GLP)

Page 11: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

•Acute to chronic tox.

•Pharmacokinetic/Toxico-kinetic

models

•Surgical models

•Gait Analysis

Species of Focus

(GLP & non-GLP)Companion animals: Dogs and cats

Page 12: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Livestock:

Porcine, Equine, Bovine,

Ovine, Poultry

Study Types

•Dermal sensitivity

•Acute/chronic tox.

•Pharmacokinetic

•Toxicokinetic models

•Surgical device

development

•Feed/nutrition

Species of Focus

(GLP & non-GLP)

Page 13: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Poultry

Studies

Page 14: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Staff &

Training

Page 15: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Sister Company: Colorado Histo-

Prep

Page 16: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Colorado Histo-Prep, Fort Collins,

CO

Page 17: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Colorado Histo-Prep Foci

•Histopathology (Anatomic

Pathology) •Dermal irritation/wound healing testing

•Implants/Tuberculosis/Arthritis

•Opthalmic/

•Inflammation(Rodent Intestinal Models)

•Fish (Whirling Disease)

•Hematology •CBC/Coagulation Testing

•CLIA Certification

•Clinical Chemistry including Eliza

•Tissue/Block/Slide Archiving

Page 18: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Tissue

Processing

Page 19: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Histology

Page 20: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Clinical

Chemistry

Page 21: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Hematology

Page 22: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Digital Micrography

Page 23: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Special Stains

Grocott’s Methenamine-Silver

Page 24: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Immunohistochemistry

Page 25: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Fluorescence

Nephron

Page 26: CARE RESEARCH, LLC€¦ · Conducted Aug 9 th – 15 th, 2012 No deficiencies found No 483 Issued Compliments on Documentation & Procedures Recent FDA Audit

Contact

Rajan S. Bawa Chief Technology Officer

Phone: (970) 493-2660

[email protected]