Drugs

CGMP Violations Seen in BRS Services Inspection

A 3/10-3/26 FDA inspection at the BRS Analytical Services drug manufacturing facility and contract testing laboratory in St. Louis, MO, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/17 Warning Letter says the specific violations were:

failure to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas, and failure to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance;
failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes; and
failure of the quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter acknowledges the firm’s 4/23 recall of redacted drug products due to CGMP deviations and lack of assurance of sterility. It also acknowledges BRS’ commitment to permanently cease production of all drugs at the facility. The company is to notify the agency if it intends to resume drug production at this or any other facility.

FDA says that, based on the nature of the violations, it recommends that BRS retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

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

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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