enforcement

Shoolin Pharma Insanitary Conditions, CGMP Issues

A 4/13-4/17 FDA inspection at the Shoolin Pharma Chem drug manufacturing facility in Mehsana, Gujarat, India, found that the company manufactures active pharmaceutical ingredients (APIs) under insanitary conditions and with significant deviations from current good manufacturing practice (CGMP) regulations for APIs. An 8/18 Warning Letter says Shoolin’s drug products are adulterated because they were prepared, packed, and held under insanitary conditions. It says the firm’s production operations are conducted in a facility that lacks adequate sanitary conditions.

FDA includes in the letter several photos depicting the insanitary conditions. The letter also lists these CGMP deviations:

failure to clean, store, and sanitize equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications;
failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure the APIs comply with established specifications and standards;
failure to design a documented, ongoing stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates; and
failure of the firm’s quality unit to exercise its responsibility to ensure the APIs manufactured at the facility comply with CGMP.

FDA says the firm’s responses to the inspection observations were inadequate. The agency acknowledges Shoolin’s 8/4 recall of all its APIs currently distributed in the U.S. market.

The letter says the company’s quality system “does not adequately ensure the integrity of data to support the safety, effectiveness, and quality of the APIs you manufacture.” It recommends that Shoolin engage a qualified consultant to evaluate its operations through a comprehensive six-system audit and then assist it in meeting CGMPs. FDA placed all of Shoolin’s drugs and drug products offered for import into the U.S. on an 8/11 Import Alert.

Shoolin was told to address the violations promptly and to ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.

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