Joan E. Adamo, PhDStudy Coordinators Organization for Research and

Education (SCORE)

13 Oct 2016

FDA Inspections: Real Experiences & Lessons Learned

The Mission of the FDA . . .

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.

. . . is two-fold

The Mission of the FDA . . .

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.

. . . is two-fold

What is the purpose of an FDA Audit?

Checking practice against procedure(do what you say)

Checking records against procedure(your documentation must prove it)

Checking to see if practice meets GCP / GLP / GMP (QSR) requirements

Pharmaceuticals Medical Devices / IVDs

Chemical / Biological Multiple mechanical and electronic components

Short lifespan Durable equipment / implanted

Toxicology Biocompatibility

Drug interactions Device malfunction

Systemic effects Local effects

Dosing error User error

Drugs and Devices including In Vitro Diagnostics (IVDs)

Pharmaceuticals Medical Devices / IVDs

21 CFR part 312 21 CFR part 812Covers research on all drugs, biologics and vaccines

Only applies to significant risk devices

Investigational New Drug (IND) Application

Investigational DeviceExemption (IDE)

Dosage form / appropriatedosing

Validated software, appropriate configurationCurrent version of device must be equivalent to proposed commercial product

Drug and Device Clinical Trial Considerations

Pharmaceuticals Medical Devices / IVDs

New Drug Application (NDA) for a New Chemical Entity 21 CFR § 314

510(k) Class I and Class II based on equivalence to a predicate device 21 CFR § 807

Long market life Rapid product lifecyclesGood Manufacturing Practices (GMP)

Quality System Regulations(QSRs) and ISO 13485

Biologics License Application(BLA) 21 CFR § 660-680

PreMarket Approval (PMA) for Class III devices 21 CFR § 814

Drug and Device Marketing Requirements

Drug and Device Inspection Highpoints

Pharmaceuticals Medical Devices / IVDsDrug accountability logs Location of unused devices

Expiration dates on products

Expiration / Calibration dates on products

Complaint Handling Implant databasesAdverse Event Logs Medical Device ReportingPatient non-compliance Product failures

Device-specific trainingSterile handling Sterile packaging

FDA conducts several types of inspections to help protect consumers from unsafe products:

• pre-approval inspection after a company submits an application to FDA to market a new product

• “for-cause” inspection to investigate a specific problem that has come to the attention of the FDA

• routine inspection of a regulated facility

When does the FDA inspect?

Observations on an FDA 483 may result from an inspection

Office of Regulatory Support

Dr. Joan E. AdamoDirector, Regulatory Support Services

University of Rochester Clinical and Translational Science Institute

265 Crittenden Blvd, Office 1.216(585) 275-0742

Joan_Adamo@urmc.rochester.edu

Do we need a quality system?

FDA Inspections

Training

Communicating with the FDA

IND & IDE Submissions