Week of October 28th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

/, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Medical Devices/Week of October 28th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

Week of October 28th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA published 13 warning letters this week including:

  • 4 sent to device firms located outside the US
  • 1 sent to a compounding pharmacy
  • And a GCP untitled letter

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CLINICAL, UNTITLED LETTER:

  • A letter from Public Citizen to both Commissioner Gottlieb and the Director of the HHS Office for Human Research Protections along with a 483 issued to Hennepin County Medical Center may be found HERE. The form 483 addresses failure in the conduct of a clinical trial of ketamine.

DEVICES:

  • Boule Medical AB (Stockholm, Sweden) received a warning letter on October 2nd 2018 based on the outcome of an inspection ending May 11th 2018. Deficiencies include but are not limited to:
    • Failure to have an adequate CAPA program. Management confirmed that the firm has no documented evidence to show they have implemented a CAPA program.
    • The firm has an inadequate compliance management process.
    • Evaluations and approvals of suppliers are not adequate because they are not evaluated for their ability to produce products that meet pre-defined specifications.
    • The firm does not have a device history record review.
    • Documentation for subassemblies are not maintained or identified by lot.
  • Cardiomed Supplies (Ontario, Canada) received a warning letter on September 21st 2018 based on the outcome of an inspection ending May 31st 2018. Deficiencies include but are not limited to:
    • There is no procedure to describe how device validation activities are to be performed.
    • CAPA procedures do not identify the quality data that will be considered within the CAPA program, nor do they identify how effectiveness will be verified.
    • The firm does not have design validation procedure(s).
  • Leventon S.A.U. (Barcelona, Spain) received a warning letter on September 5th 2018 based on the outcome of an inspection ending March 22nd 2018. Deficiencies include but are not limited to:
    • The firm has not validated all appropriate processes.
    • The firm has not established how they will validate changes made to the manufacturing process.
    • The firm failed to establish and maintain acceptance procedures to ensure requirements for in-process requirements are met.
    • Failure to submit 30-day reports to FDA.
  • Gaeltec Devices LTD (Dunvegan, UK) received a warning letter on July 2nd 2018 based on the outcome of an inspection ending December 7th 2017. Deficiencies include but are not limited to:
    • The firm failed to validate a new sterilization process they implemented.
    • Effectiveness of CAPAs were not verified.
    • Complaint files were not maintained.
    • Equipment was not appropriately designed and constructed and maintained to ensure it was adequate for its intended use.
    • The firm does not have an approved PMA to support the product.

COMPOUNDING PHARMACY:

  • Custom RX LLC (Witchita, KS) received a warning letter on October 10th 2018 based on the outcome of an inspection ending August 15th 2017.

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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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