Drugs

Multiple Drug, Medical Device Violations at Tarmac Products

David McFarland

— 2 min read
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A 9/9-9/27/19 FDA inspection at Tarmac Products, Miami Gardens, FL, found multiple violations in the firm’s manufacturing of over-the-counter drug products and wound dressing medical devices. A just-released 11/9/20 Warning Letter lists violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and Quality System regulations for medical devices. The letter also says the company is distributing an unapproved new drug.

Specific drug CGMP violations were: 

  •          failing to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
  •          failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
  •          failing to follow an adequate written testing program designed to assess the stability characteristics of drug products;
  •          failing to routinely calibrate, inspect, or check, according to a written program designed to assure proper performance of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product; and
  •          failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

The letter says the firm’s Hypercare is intended for use as an antiperspirant and is defined as a drug that is subject to the final rule for antiperspirant drug products for over-the-counter human use. “This product is not labeled or formulated in accordance with this final rule,” FDA says. Because the product does not comply with the final rule and the agency is not aware of sufficient evidence to show that it is generally recognized as safe and effective as formulated and labeled, FDA says it considers it to be a new drug that is being marketed without agency approval.

The specific medical device Quality System violations were: 

  •          failing to adequately validate, according to established procedures, a process whose results cannot be fully verified by subsequent inspection and test;
  •          failing to establish and maintain procedures to control product that does not conform to specified requirements;
  •          failing to establish and maintain procedures for design verification to confirm that design output meets the design input requirements;
  •          failing to establish and maintain design change procedures;
  •          failing to ensure that all equipment used in the manufacturing process meets specified requirements;
  •          failing to establish and maintain calibration procedures that include specific directions and limits for accuracy and precision and, when accuracy and precision limits are not met, provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality; and
  •          failing to establish and maintain procedures for corrective and preventive actions.

FDA says that because the firm has failed to correct repeat violations, it strongly recommends engaging a qualified consultant to assist it in meeting CGMP requirements. Tarmac was told to correct the violations promptly and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of all the corrections and corrective actions taken, and a timetable for implementation of all corrective activities.

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