FDA posted 11 warning letters this week:

  • 3 were issued to duodenoscope manufacturers (we identified those last week)
  • 2 warning letters went to device firms
  • 1 to a contract testing laboratory in France
  • 1 to a compounding pharmacy


  • Quali-Controls & Quali-Controle C.E. BAC (Meru, France) received a warning letter on March 5th 2018 based on the outcome of an inspection ending September 15th 2017.  Deficiencies include but are not limited to:
    • Compendial test methods are not validated. The firm did not perform a retrospective analysis using unvalidated test methods. FDA asks for the following in response to the warning letter:
      • “Protocol and timelines for the validation or method transfer of all non-compendial methods, and verification of all compendial methods used at your facility to test products for release.
      • An assessment of the use of unvalidated and unverified methods on products released to the U.S. market, and your plans to communicate with your customers regarding previously tested drugs for which you used unvalidated or unverified methods.
      • Your procedure to assure that all future non-compendial methods used in your facility are properly validated or transferred, and all compendial methods are verified prior to use.” 
    • OOS results were invalidated without investigation or justification. It appears that samples were simply tested into compliance. FDA reminds them that they must comply with CGMPs — which includes investigation of OOS events. FDA also reminds them that contractors function as ‘extensions of the manufacturer’s own facility.’ FDA requests that the firm provide the following:
      • Retrospective review of all OOS test results to determine if results were invalidated without scientific justification. Your review should also identify those instances where a documented investigation was not performed, and your plans for communicating these deviations with your clients. Submit a report of your review with the findings, and your CAPA plan to prevent recurrence.
      • Your revised written procedure for OOS investigations.
    • The firm was not in compliance with their Quality Agreement with at least one customer. The firm did not test components with the specified method, nor did they notify the customer that a different method was used.


  • Laser Dental Innovations (San Jose, CA) received a warning letter on February 27th 2018 based on the outcome of an inspection ending December 14th 2017. The firm makes dental handpieces and laser fiber optic surgical devices. Deficiencies include but are not limited to:
    • Documentation of the firms CAPAs are not adequate because they are not documented on the appropriate form while they also do not include root cause analysis and investigation as required by the firm’s SOP.
    • Customer complaint management process is not adequate because the firm did not have records identifying the information they are required to maintain.
    • At least one product is not supported by a risk analysis. Further, the first stated that they do not have design validation or design verification records for the same product.
    • Contracts are not in place with suppliers, nor have the suppliers been evaluated for their ability to meet specifications.
    • Device History Records do not include complete information.
    • The firm has not conducted internal audits since 2011.
  • Dexcowin Co., Ltd (South Korea) received a warning letter on February 20th 2018 based on the outcome of an inspection ending August 31st 2017. The firm manufactures portable dental diagnostic X-ray devices. The warning letter identifies thirteen deficiencies that include but are not limited to:
    • The firm’s CAPA efforts are inadequate because the firm does not verify the effectiveness of the actions taken. The firm did not include remediation of complaints for problem batteries through the CAPA systems.
    • The firm does not conduct design validation.
    • The firm does not have adequate procedures to address ‘identification, documentation, validation, or appropriate verification, review and approval of design changes before their implementation…’
    • Testing equipment is not qualified for its intended purpose.
    • Device History Records do not include all of the information required by 8280.184.
    • The firm does not have documentation to ensure that staff have adequate training.
    • The firm does not have evidence that the appropriate management attended management review consistent with their procedures.
    • FDA is not immediately notified of accidental radiation occurrence reported to the firm.


  • MedPark Pharmacy LLC received a warning letter on March 5th 2018 based on the outcome of an inspection ending March 10th 2017. The letter identified five deviations from GMP.