Data Integrity Concerns, Quality Controls Prompt 483 for Specialty Drugmaker

February 5, 2017

Unrestricted access to electronic records and a series of quality control deficiencies resulted in a seven-observation 483 for a specialty drugmaker based in Maryland.

American Antibiotics failed to limit system access to electronic data and implement audit trail requirements to ensure records are trustworthy, reliable and equivalent to paper records, according to the Form 483 issued after a December 2015 inspection of the company’s Baltimore facility.

Without restricted access, laboratory analysts are authorized to write and edit test methods and laboratory personnel have administrator access to electronic records, which cast doubt on the reliability of the company’s recordkeeping. A lack of audit trail reviews intensified the agency’s concerns regarding the integrity of American Antibiotics’ data.

The FDA also cited the facility for not disclosing the responsibilities and procedures applicable to its quality control unit in writing and for failing to charge the quality control unit with approving and rejecting all procedures or specification for the company’s drugs.

Unapproved procedural deviations for storage components, test procedures, and labeling were among the final observations in the 483.

This management report, Effective 483 Responses: Focus on CAPA Violations, will guide you to the best responses to 483 letters. From tone and language used in responses to responding in the 15-day time limit. Most of that time will go toward bringing your CAPA program into compliance. Don't waste a second trying to figure out how to communicate those plans in a way that will convince the FDA you are focused on improvement and committed to quality.

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