FDA Warning Letters Week of 4/6/2020: Devices, BIMO

FDA continues to post warning letters to firms distributing unapproved products to diagnose, prevent and treat COVID-19 infections.  Among the warning letters we follow, this week FDA posted one to a drug manufacturer, two to device firms, and one to a clinical investigator conducting studies on a device.


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DRUGS | Global Treat Srl (Romania)

Global Treat Srl received a warning letter on March 31, 2020 based on the outcome of an inspection ending September 13, 2019.  The firm also manufactures an OTC product that is deemed to be an unapproved new drug.  They also serve as a CMO for at least one product.  The firm was placed on Import Alert 66-40 on March 17, 2020, and the FDA also recommended they hire a qualified consultant to assist them in coming into GMP compliance.

Deficiencies include but aren’t limited to:

  • The firm does not test drug product for identity and strength of active ingredient(s) prior to releasing the product for distribution.  The firm committed to testing for active ingredients “for which there are testing methods.”  FDA did not accept this response and stated that if methods do not exist, the firm should develop them.  Further, the firm did not commit to testing reserve samples of products within expiry that have been distributed in the US.  And finally, the response did not include sufficient information and a timeline for implementation of remediation activities.
  • The firm relied on Certificates of Analysis for acceptance of materials and components from suppliers.  The suppliers are not qualified.  FDA deemed the firm’s response inadequate because it lacked detail and did not include proof that methods are validated or suitable for their intended use.
  • The Quality Unit is not exercising their authority or responsibility.  They do not review production and control records and the firm lacked written procedures describing their roles and responsibilities.  For example, production reviewed and approved microbiological tests results and released the product for distribution; the general manager reviews and approves procedures related to production and quality.  Finally, there is no documentation that describes the responsibilities for receiving, investigations and reporting of complaints and adverse events between the firm and their client for whom they manufacture drug product.

DEVICE, CLINICAL INVESTIGATOR | Philip R. Kennedy (Duluth, GA)

Philip R. Kennedy received a warning letter on February 27, 2020 based on the outcome of a BIMO inspection ending October 16, 2019.  The inspection was conducted for a device under clinical evaluation.  The warning letter cites various sections of 21CFR812 with which the investigator did not comply.

Deficiencies include but aren’t limited to:

  • The investigator could not provide documentation that the study was under continued review by an IRB between 2002 and 2019.  While the study investigator said there was no study ongoing to monitor after 2010, he continued to collect study data in 2013.
  • The study investigator had reports labeled as “Annual Report to the Food and Drug Administration” for several years, though the FDA records do not show any such reports.  Also missing are other reports that the study investigator stated were submitted to the IRB.
  • The study investigator failed to maintain records of device accountability and failed to retain all source study records.

DEVICE | Dongguan Microview Medical Technology Co., LTD (China)

Dongguan Microview Medical Technology Co. LTD received a warning letter on September 20, 2019 based on the outcome of an inspection ending June 27, 2019.  The firm manufactures MicroView Disposable Endoscopic Cannula.  FDA is taking steps to implement an import alert to prevent receipt of these products in the US, but it was not effective as of the warning letter date.

Deficiencies include but aren’t limited to:

  • Bins of finished devices and subassemblies were seen during a facility tour but these were not identified as to the product or their status.  An employee identified them to be non-conforming product.
  • The firm failed to adequately validate the EO sterilization process.
  • The firm did not revalidate the primary sealing process after it was moved to a new facility.
  • Effectiveness verifications for CAPA activities were not conducted and documented.
  • Adequate training records were not available.  The example provided was for internal auditors.
  • Device history files were not maintained and did not address changes made in the manufacture of the device.  The firm claimed that “...the validation report, supporting data and record were lost.”

DEVICE | Mandelay KFT (Hungary)

Mandelay KFT received a warning letter on February 3, 2020 based on the outcome of a BIMO  inspection ending October 17, 2019.  The firm manufactures “Scientific Consciousness Interface Operation (SCIO) System and the Quantum University Energetic System Technology 9 (Quest 9) devices.”  FDA is taking steps to put products from the site on import alert but this was not completed at the time the warning letter was issued.

Deficiencies include but aren’t limited to:

  • The design control procedures are not adequately implemented.  The firm’s design verification of various hardware requirements is not documented in the DHF.  Further corrections were made to software to address problems in this area, but the verification testing does not identify which test cases were related to the software corrections.  And finally, the firm did not respond to observation #1 on the form 483.
  • The software-related complaints received by the firm are not documented or investigated as required in the Quality Manual.
  • In response to FDA’s concerns regarding what seems to be periodic inspection and testing of specific equipment, the firm sent documentation that did not address the observation.  Further, “Although your firm provided back-dated training records, it is not clear if your training has been done since your training document is not signed.”  So the firm took one problem and made it into a bigger problem related to the authenticity and trustworthiness of the firm’s records.
  • Labeling is not adequately controlled and at least one device does not include a primary identification label and labeling use.  And once again, the firm did not address observation #4 of the form 483.

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