FDA warns Ohio company for serious violations in drug repackaging process

Safecor, FDA inspection, drug repackaging, warning letter, Ohio, quality, safety issues, violation

Ohio-based pharmaceutical repackaging company, Safecor Health, finds itself in the FDA’s crosshairs as it receives a stern warning letter highlighting four “significant violations” discovered during an inspection of its facility in Woburn, Massachusetts, conducted in March.

The warning letter, now prominently featured on the FDA’s website, unveils a series of concerns stemming from the inspection. These violations include shortcomings in Safecor’s inspection process for packaging and labeling facilities, which raise the specter of potential drug mix-ups. For instance, an FDA inspector encountered a disconcerting scenario where various capsules and tablets were found in the vicinity of a blister packaging machine during the packaging of chewable aspirin tablets, despite records indicating that a line clearance procedure had been executed.

The FDA’s letter underscored the company’s history of complaints related to product mix-ups, noting that Safecor had previously initiated internal recalls in response to customer complaints.

The inspection further revealed that Safecor had failed to establish and implement adequate written protocols for equipment cleaning and maintenance. Additionally, it neglected to conduct proper testing on samples of each drug component to ensure compliance with the specified standards for purity, strength, and quality.

As per FDA four main points are quoted in the warning letter:

  1. Your firm does not adequately inspect the packaging and labeling facilities immediately before use to assure that all drug products have been removed from the previous operations 
  2. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment
  3. Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality
  4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity

Inspectors also took issue with Safecor’s quality control unit, which they found to be falling short of the requisite drug manufacturing standards. The agency’s report detailed instances where partially completed and torn-up manufacturing records for a lot of children’s acetaminophen were observed, alongside stacks of loose printed forms situated near the repackaging area.

In response to these concerning findings, the FDA recommended that Safecor enlist the services of a manufacturing consultant. The implication is clear: if these issues are not promptly and effectively addressed, the FDA retains the option to withhold export certificates and drug approvals from Safecor.

In a field distinct from drug manufacturers who produce their medications in-house, repackagers like Safecor play a vital role in the pharmaceutical ecosystem. They specialize in repackaging premade drugs with new labels, facilitating the distribution of medications to the public.

As Safecor Health navigates the challenges presented by this FDA warning letter, the pharmaceutical industry watches closely, aware of the far-reaching consequences that regulatory actions of this nature can have on patient safety and the integrity of the drug supply chain.

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