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FDA cGMP warning letters round up

By Nick Taylor , 06-Jan-2011

in-PharmaTechnologist.com presents a round up of cGMP related warning letters published recently by the FDA.

The US Food and Drug Administration (FDA) ended 2010 by publishing a number of warning letters detailing alleged deviations from current good manufacturing practices (cGMP).

In a warning letter to McGuff Pharmaceuticals the FDA said its response to initial observations lacked sufficient corrective actions. During a May inspection of the Santa Ana, California site the FDA found a lack of appropriate written procedures to prevent microbiological contamination.

Other issues raised by the FDA include: the need to adequately qualify ingredient suppliers to ensure sterile drug quality; and failure to conduct adequate investigations into action level excursions.

The FDA visited Synbiotics , an India-based producer of active pharmaceutical ingredients (APIs), in August 2010. Last month, after reviewing corrective actions, the FDA issued the company with a warning letter covering incomplete process validation and documentation.

Your firm denied our investigator access into the facility, and instead requested that the investigator remain in a business office. Information and limited documents provided to the investigator for review revealed significant deviations from cGMP for the manufacture of APIs.”

Synbiotics is expected to produce a timeline of when process validation, essential procedures and critical quality functions will be implemented. The FDA plans to re-inspect the facility in Vadodara, India.

Klinge Chemicals was issued with a warning letter on December 21. The letter follows a June 2010 inspection of an API plant in Glasgow, Scotland and FDA review of corrective actions from Klinge.

Specific deviations detailed by the FDA include failure to: ensure water is of appropriate quality for use in the final step of API purification; establish an API stability monitoring programme; and meet US Pharmacopeia (USP) standards for finished product assay determination.

An April 2010 inspection of a Macco Organiques API plant in Salaberry-De-Valleyfield, Canada has led to an FDA warning letter . In the letter the FDA said Macco lacked adequate laboratory controls and live flying insects were found in a large opened bag next to production equipment.

Yuki Gosei Kogyo has received an FDA warning letter after the agency found the company’s response lacked sufficient corrective actions. During a July 2010 inspection of the API plant in Fukushima, Japan the FDA noted failure to ensure proper validation of analytical methods.

A July 2010 inspection of GAR Laboratories ’ plant in Riverside, California observed failure to establish an adequate quality control unit with responsibility to approve or reject all components.

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