The US regulator criticised Concept in a warning letter last week in which it also reiterated violations observed during an inspection of the site - No. 33, The Third Branch Saida Road, Xiqing Economic Development Area, Tianjin – conducted last August.
The agency said although the firm had acknowledged the significance of the current good manufacturing practice (cGMP) violations when it responded last year, it “did not commit to any corrective actions.”
The violations – which related to product quality and stability testing procedures and the lack of written procedures for production processes and cleaning – earned Concept a Form 483 from the agency last year.