Regulatory Focus™ > News Articles > Warning Letter Analysis: FDA Warning Letters Cite Companies for Marketing, CGMP, Design Deficiencies

Warning Letter Analysis: FDA Warning Letters Cite Companies for Marketing, CGMP, Design Deficiencies

Posted 16 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released five warning letters previously issued to companies in the healthcare product sector, including three medical device companies, one pharmaceutical distributor and one supplement manufacturer.

William Demant Holdings A/S (Medical Device)

FDA's warning letter to William Demant, a Danish medical device manufacturer, cited deficiencies at its Oxford, UK facility found during two December 2011 inspections. The company, which manufacturers tympanometers and audiometers, was found to be in violation of the Federal Food, Drug and Cosmetic Act(FD&C Act) in ten areas.

These areas include:

  • Failure to controls for the design of its devices, including verification, identification, documentation and validation of its devices
  • Failure to establish procedures to receive, review and evaluate adverse event reports
  • Failure to control out-of-specification devices
  • Failure to keep device history records
  • Failure to validate computer software used to validate devices
  • Failure to adequately calibrate devices using established procedures
  • Failure to establish procedures for internal quality audits
  • Failure to establish procedures for training facility personnel

Progressive Medical, Inc. (Medical Device)

FDA's warning letter to Progressive Medical cited the Missouri-based medical device manufacturer for many of the same alleged deficiencies as William Demand, finding the firm to be lacking in its established procedures to: implement corrective and preventive action, maintain the design plans for its products, exercise control over contractors and suppliers, control documents, and review the suitability and effectiveness of its quality systems regularly.

FDA also cited Progressive Medical for "significant violations," including "failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17."

"For example, your firm does not have an MDR procedure to indicate when a reportable event should be reported to FDA," wrote John Thorsky, director of FDA's Kansas City District.

Andersen Sterilizers Inc. (Medical Device)

In a warning letter to Andersen Sterilizers, FDA said it found the North Carolina-based manufacturer of sterilizers in violation of the FD&C Act because it does not have an approved application for premarket approval (PMA) and did not notify FDA of its intent to market the device.

Even beyond this major purported violation, FDA said Andersen had failed to establish medical device reporting and evaluation procedures, failed to establish processes to ensure device quality and adherence to specifications, failure to conduct quality audits and failure to regularly review its quality system.

Quadex Pharmaceuticals, LLC(Pharmaceutical Distributor)

FDA's warning letter to Quadex Pharmaceuticals cites the company for marketing deficiencies, alleging the company is marketing an unapproved cold sore treatment in violation of the FD&C Act.

FDA notes Quadex's marketing language calls attention to its Viroxyn product's ability to treat the herpes simplex virus, which causes cold sores. FDA further notes the product, which it says meets the definition of a drug product, violates labeling regulations and has not been proven to be safe or effective by the agency.

"According to your labeling, the active ingredients in "Viroxyn Professional" include benzalkonium chloride," wrote LaTonya Mitchell, director of FDA's Denver District Office. "Benzalkonium chloride use in a product that among other uses is intended to treat cold sores and fever blisters is not, nor has it ever been, covered by the developing monographs for OTC cold sore/fever blister drug products."

Continued Mitchell: "In addition, statements in your labeling suggest that your product is intended for OTC drug use in the treatment of herpes. This indication is not covered by any monograph or ongoing rulemaking under the OTC Drug Review."

FDA also said it was concerned Quadex, which formerly marketed a similarly-sanctioned product known as "Blister Blaster," could be marketing other products thought to have been removed from the market.

"We request that in your reply, you address whether you have permanently ceased distribution of "Blister Blaster," and if not, address how you would assure that this product also complies with the requirements of the FD&C Act," said Mitchell.

Reaction Nutrition, L.K.C. (Dietary Supplement)

FDA's warning letter to Reaction Nutrition alleges the Pennsylvania-based manufacturer and packaging company is guilty of selling adulterated products as a result of the company failing to adhere to current Good Manufacturing Practice (cGMP) regulations.

Reaction Nutrition's cGMP violations include failing to ensure adherence to product specifications, releasing products known to be significantly out of specification, failing to have a quality control team separate from its management department, failure to prepare and maintain a master manufacturing record for each supplement formulation, failure to produce or prepare master manufacturing records (MMRs), failure to verify the quality of finished products, and failure to keep written records of manufacturing procedures.

FDA also cited Reaction Nutrition for making therapeutic claims in its labeling for its Live Capsules product, which would make it regulated as a new drug product under the FD&C Act. Further, the claims made on the Live Capsules label are for indications that are "not amendable to self-diagnosis and treatment by individuals who are not medical practitioners," wrote Kirk Sooter, district director of FDA's Philadelphia District office.

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