FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Data Integrity Concerns, Quality Controls Prompt 483 for Specialty Drugmaker

Jan. 11, 2017

Unrestricted access to electronic records and a series of quality control deficiencies resulted in a seven-observation Form 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 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 the company’s data.

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