Manufacturing

Exposure

Manufactures of medical device and pharmaceuticals are expected to meet all regulatory requirements as set forth by the FDA. The guidance is intended to help manufactures implement quality systems and risk management approaches to ensure safety, efficacy, and complaince. 

What Can Happen

If a manufacturer's product does not meet regulatory requirements, the result may be injuries and death related to unsafe products, time-consuming regulator agency reporting procedures, product recalls, litigation, and loss of revenue. 

Top Recall Regulatory Violations

Design controls - receiving, in-process, and finished

820.30

703

1,759

36

Device acceptance

820.80

204

1,068

61

Production and process controls

820.70

119

830

58

Nonconforming product

820.90

17

415

28

Process validation

820.75

16

390

30

Purchasing controls

820.50

19

366

29

Device packaging 

820.130

0

377

5

Device labeling

820.120

2

271

29

Personnel

820.25

0

159

2

Corrective and preventative action

820.100

0

122

7

How to Reduce Risk

Ensure the company has a comprehensive approach, with well-defined management responsibilities:

  • Quality Control Assurance

    • Quality reporting and management support​

    • Formal and documented quality metrics

    • Compliance with industry standards (e.g. ISO, cGMP, UL, etc.)

    • cGMP compliance and facility sanitation controls

  • Sales and Marketing

    • Legal review of products, packaging, inserts, and advertising materials​

    • Standard operating procedures to manage salespersons in a clinical environment

    • Annual training for regulatory, sales, and service/maintenance personnel

    • Standard operating procedures for managing and responding to off-label use

    • Formal and documented customer or end-user training

  • Post-Market Surveillance

    • Periodic review of FDA databases and industry new sources (e.g., TPLC, MedWatch, MedSun) for up-to-date information about similar products that have experienced adverse events, Medical Device Recalls (MDRs), and complaints​

    • Compliance with FDA post-market surveillance requirements

    • Crisis management program

    • Product recall standard operating procedures

  • Complaint Handling

    • Formal Corrective An Preventative Action (CAPA) program​

    • Protocols for receiving and recording complaints

    • Protocols for escalating complaints to senior management

Contact us to learn more about how we can help protect your organization.

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