P R E P A R I N G F O R A N F D A

I N S P E C T I O N

A D A P T E D B Y L E O J . L A G R O T T E F R O M P E R S O N A L E X P E R I E N C E , P R E S E N T A T I O N S & B Y O T H E R F O R M E R

F D A I N V E S T I G A T O R S .

Florida Medical

Manufacturers Consortium

May 14, 2018

WHY DO WE NEED A SUCCESSFUL INSPECTION?

• Prevent Regulatory action

• Ensures consumer safety

• Your professional reputation

• Freedom from legal problems

• Verify our continuous improvement process

• Increased Customer Response via Sales

2

WHO’S ON THE INSPECTION TEAM?

• All QA/RA

• Engineers/Chemists

• Investigators

• Microbiologists

• Computer Specialist

• Headquarters Reviewer

3

7 SUBSYSTEMS OF THE QUALITY SYSTEM

Material Controls

Records/

Documents/

Change Controls

Design Controls

MANAGEMENT

Corrective

&

Preventive Actions

Production

&

Process Controls

Facility

&

Equipment Controls

Sterilization

Process

Controls

Medical Device

Tracking

Reports of Corrections and

Removals Medical Device

Reporting

WHAT WILL THEY LOOK AT? DEPENDS ON THEIR ASSIGNMENT!

• Complaints/Service/CAPAs/NCRs

• Computers/Software/eMDR

• QM, Procedures and Work Instructions

• Rejected batches

• Validation and Sterile Processes

• Overall facility

• Buildings, equipment, materials, cleaning procedures, HVAC, etc.

• Design Controls and Especially Risk Management

• New High Risk Devices, 510(k), Change Controls

• Labels and Packaging, Are you GUDID Compliant

• Components and Nonconformances reported in

• In-process materials and systems

• Validation processes including Sterilization

• Final Release Activities

• Logbooks, records and documents

• Areas not looked at before-Be Ready

5

WHAT SHOULD YOUR COMPANY BE DOING PRIOR TO THE INSPECTION ?

• Review all new designs; design changes and major NC since last inspection.

• Review your performance since last inspection (Internal Audits and CA).

• Provide continuing verifiable cGMP training to all employees.

• Taking broad steps to communicate the importance of the expected FDA inspection to all management and employees.

• Ensure Resources are available to review QS to ensure regulatory compliance. (continual)

• Identifying inspection coordinators.

• Developing an inspection response plan.

• Establishing communication procedures.

• Designating key personnel responsibilities.

• Establishing written policies-photos; recordings; etc.

• Enhancing your continuous improvement process.

6

WHAT SHOULD I DO PRIOR TO THE INSPECTION?

• Support preparation efforts. • Ensure your work area is neat and orderly. • Ensure your area equipment and instruments are

clean and calibrated. • Ensure your logs and production documents are

filled out completely, accurately and legibly at time of performance.

• Be prepared. • Know your job. • Encourage your fellow workers. • Expect high quality in all your work-accept

nothing less. • Remember: First impressions are lasting

Impressions; Employees, facilities and high quality documents make a lasting impression with the FDA! 7

WHAT CAN I DO DURING THE INSPECTION?

• Listen carefully to questions.

• Don’t assume you know the question.

• Answer only after the question is fully stated.

• Be confident of your answer. If you don’t know, say so.

• Avoid bragging about your area.

• Don’t be nervous.

• Re-review all your procedures.

• Provide only what is asked for.

• Don’t leave documents out on your desk.

• Keep your area clean. Be ready any day!

• Be proud of your area but the best of things are left

unseen.

8

HOW DO I ANSWER AN INVESTIGATOR’S QUESTIONS? • Do’s

• Don’ts

9

DO

• Be prepared. • Be professional. • Provide documents in a timely fashion. • Answer questions directly and honestly. • Recognize“ I Don’t Know” is an acceptable

answer.

Don’t • Guess or estimate. • Volunteer information. • Provide any misinformation. • Provide misleading information. • Show temper or be argumentative 10

R E S P O N D I N G T O

T H E F O R M F D A - 4 8 3

Florida Medical

Manufacturers Consortium

May 14, 2018

7 STEPS TO RESPOND TO FDA 483 INSPECTIONAL OBSERVATIONS

• Respond to the FDA 483 violation(s) in less than 15 business days

– Use New Electronic Format to Appropriate Compliance Division

• Use your CAPA forms instead of a memo

– First Page prepare a Cover Letter backed by all CAPAs and Corrective Actions

• Document the investigation and root cause

• Don’t forget containment and correction

– If a market withdrawal or Recall is planned, demonstrate containment of affected

product before end of inspection with plan to continue if completed.

• Explain the corrective action plans and timelines

– Send all documents corrected, SOPs, Work Instructions, Training Records

• Show the FDA you have already taken action

– Demonstrate initiation of CAPAs or Document corrections before end of inspection

• Follow-up before the FDA does

– At a minimum every 30 days or as corrective actions are completed

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NEW FDA CONTACT INFORMATION

Florida is under the new reorganization of Office of Regulatory Affairs Office of Medical Devices and Radiological Health Operations (OMDRHO) Division 2 – Central

555 Winderley Place, Suite #200

Maitland, FL 32751

Area Under Division 2- AL; FL; GA; IA; IL; KS; LA; MN; MO; MS; NC; ND; NE; SC; SD; TN; WI; Puerto Rico and Virgin Islands

Send all correspondence via email: ORADevices2FirmResponse@fda.hhs.gov

Label all attachments and keep each file less than 100MB. If greater send multiple emails

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THANK YOU

DISCUSSION & QUESTIONS

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Leo J. Lagrotte Senior Consultant ljl@qss-llc.com 941-920-2645

www.qss-llc.com