Repeated CGMP Violations at Altaire

A 3/25-4/19/19 FDA inspection at Altaire Pharmaceuticals, Aquebogue, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals that were repeated violations from three previous inspections. A just-released 3/12 Warning Letter said the specific violations were:

•          failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas;
•          failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
•          failing to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination;
•          failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes; and
•          failing 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 its cleaning and maintenance.

The agency says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. It acknowledges that Altair intends to use a consultant to assist in data integrity remediation. The company was told to submit (1) a comprehensive investigation into the extent of the data record and reporting inaccuracies, including all data deficiencies that were submitted to FDA as part of applications that ultimately were approved based on the firm’s review and release of the data; (2) a current risk assessment of the potential effects of the observed failures on drug quality, and (3) a management strategy for the firm that includes details of a global corrective and preventive action plan.

The company also committed to using a consultant to resolve its CGMP issues. FDA recommends that the consultant evaluate the firm’s operations to assist it in meeting CGMP requirements and also perform a comprehensive audit of its entire operation for CGMP compliance.

The letter says FDA cited similar CGMP observations in inspections in 2013, 2015, and 2017. “You proposed specific remediation for these observations in your response,” it says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

Altaire was told to correct the violations promptly and to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence with a schedule for implementation of all the actions.