FDA 483 - A.I.G Technologies Inc. - July 01, 2011
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A.I.G Technologies, Inc. in Deerfield Beach, FL, was cited with nine observations during an FDA inspection from June 27 to July 1, 2011, highlighting significant deficiencies across its manufacturing operations. The firm lacked a functional quality control unit, proper employee training, and adequate sanitation practices. Key issues included failures in record-keeping for equipment and processes, insufficient material control, and a lack of validated procedures for production and product preservation, indicating a broad non-compliance with good manufacturing practices.
ID · 53d9976c-d453-4b5c-b129-699226c1fdcb