FDA Sent These 4 Warning Letters for Medical Device Companies | Oct – Dec 2017

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FDA Sent These 4 Warning Letters for Medical Device Companies | Oct – Dec 2017

We took a snapshot of the 4 warning letters the FDA sent to medical device companies last quarter.  Device manufacturing violations ranged from failing to evaluate complaints to failing to establish procedures for quality audits.

From device manufacturers in India, Lithuania, and more, here they are (starting with the most recent):

  • Telemed, Lithuania – 16 violations:
    • Failure to establish and maintain adequate design plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b).
    • Failure to establish and maintain adequate procedures for design input, as required by 21 CFR 820.30.
    • Failure to establish and maintain design verification procedures to confirm design output meets design input requirements, as required by 21 CFR 820.30(f).
    • Failure to establish and maintain adequate procedures for validating the device design.
    • Failure to establish and maintain design transfer procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h).
    • Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a).
    • Failure to establish and maintain receiving acceptance activities procedures for acceptance of incoming product, as required by 21 CFR 820.80(b).
    • Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100.
    • Failure to establish and maintain adequate purchasing control procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
    • Failure to establish and maintain adequate process control procedures to ensure the device conforms to its specifications, as required by 21 CFR 820.70(a).
    • Failure to establish and maintain procedures to control environmental conditions, as required by 21 CFR 820.70(c).
    • Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
    • Failure to establish and maintain adequate procedures for training and identifying training needs, as required by 21 CFR 820.25(a).
    • Failure to establish and maintain adequate document control procedures, as required by 21 CFR 820.40(a).
    • Failure to establish and maintain adequate procedures for quality audits, as required by 21 CFR 820.22.

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  • ProSun International, LLC, Saint Petersburg, FL – 8 violations:
    • Failure to establish procedures for finished device acceptance, as required by 21 CFR 820.80(d).
    • Failure to establish corrective and preventive action procedures, as required by 21 CFR 820.100(a).
    • Failure to establish procedures for document control, as required by 21 CFR 820.40.
    • Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
    • Failure to establish procedures to control environmental conditions, as required by 21 CFR 820.70(c).
    • Failure to maintain a device master record, as required by 21 CFR 820.181.
    • Failure to establish procedures for quality audits, as required by 21 CFR 820.22.
    • Failure to submit a written Report of Correction or Removal to FDA for a medical device correction or removal initiated to reduce a risk to health or remedy a violation of the Act caused by the device which may present a risk to health, as required by 21 CFR 806.10.
  • GPC Medical Limited, New Delhi, India – 4 violations:
    • Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).
    • Procedures for finished device acceptance have not been adequately established as is required by 21 CFR 820.80(d).
    • Procedures to control labeling activities have not been adequately established as is required by 21 CFR 820.120.
    • Failure to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record as is required per 21 CFR 820.184
  • Kelyniam Global, Inc., Canton, CT – 7 violations:
    • Failure to establish and maintain design change procedures, pursuant to 21 CFR 820.30(i).
    • Failure to evaluate complaints to determine whether the complaint represents an event which is required to be reported to the FDA under 21 CFR Part 803, Medical Device Reporting, pursuant to 21 CFR 820.198(a)(3).
    • Failure to demonstrate that the device was manufactured in accordance with the device master record, pursuant to 21 CFR 820.184.
    • Failure to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures, pursuant to 21 CFR 820.75(a).
    • Failure to establish procedures for acceptance of incoming product, pursuant to 21 CFR 820.80(b).
    • Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system, pursuant to 21 CFR 820.20(c).
    • Failure to establish corrective and preventive actions procedures, pursuant to 21 CFR 820.100(a).

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About the Author

Barbara W. Unger

Barbara W. Unger formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

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