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

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.