Drugs

CGMP Violations at Thibiant International

A 3/6-3/15/18 FDA inspection at Thibiant International, Newbury Park, CA, found significant violations of current good manufacturing practice (CGMP) regulations in its production of finished pharmaceuticals. A 3/6 Warning Letter says the specific violations were:

failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet its specifications, whether or not the batch has already been distributed;
failing to follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration;
failing to establish the reliability of the component supplier’s analysis through appropriate validation of the supplier’s test results at appropriate intervals; and
failing to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit.

FDA says that significant findings in the letter indicate that the firm’s quality control unit is not fully exercising its authority and/or responsibilities. It recommends that Thibiant retain a qualified consultant to assist it in meeting CGMP requirements.

Thibiant was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome