483
BC3 TECHNOLOGIESFDA 483 - BC3 TECHNOLOGIES - November 26, 2024
Record Details
BC3 Technologies in Baltimore, MD, a specification developer, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to establish adequate procedures for design control, complaint handling, supplier management, and corrective and preventive actions. Additionally, issues were noted with packaging validation, complaint investigation records, design output documentation, and statistical sampling techniques.
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ID · 713e6d5d-2706-4a1d-a663-89e58b7501fe
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