INSPECTION UNCOVERS MOLD GROWTH, LEADS TO WARNING LETTER
An in vitro diagnostic manufacturer failed to investigate root causes of nonconformances, including fungus and mold growth, the FDA said in a recent warning letter.
The FDA cited Pointe Scientific for at least 10 nonconformances including stability failures, fungus and low recoveries. No investigations were conducted to determine root causes, the agency said.
The agency said the firm did not establish effective and complete procedures to implement corrective and preventative actions.
Pointe Scientific also failed to conduct investigations into complaints, said the FDA. The firm received approximately seven complaints involving the Liquid Glucose Hexokinase (Hitachi), 20 complaints involving the Liquid Alkaline Phosphatase, four complaints involving the Liquid Glucose Hexokinase and five complaints involving the Ammonia and Alcohol Control and Alcohol Standard.
The warning letter, issued Aug. 11 and posted to the FDA website Aug. 29, came after a facility inspection May 4 June 16. Other violations listed included:
Failure to follow procedures for controlling product storage to prevent mix-ups, damages or other adverse effects;
Failure to establish and provide training to ensure employees adequately perform their assigned responsibilities;
Failure to validate manufacturing processes; and
Failure to establish effective and complete procedures for addressing nonconforming product.
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