Rhyz Analytical Labs CGMP Violations

A 6/2-6/5 FDA inspection at the Rhyz Analytical Labs contract testing laboratory in Provo, UT, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 11/12 Warning Letter says the specific violations were:

• failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed; and
• failure to establish adequate written responsibilities and procedures applicable to the quality control unit.

The letter says the firm’s responses to the inspection observations were inadequate.

Rhyz was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.