483
Hit Promotional Products Inc.FDA 483 - Hit Promotional Products Inc. - August 02, 2019
Record Details
Hit Promotional Products Inc., an OTC Drug Product Labeler in Saint Petersburg, FL, was cited for significant deficiencies in its quality control unit. The inspection revealed a lack of cGMP systems, inadequate written procedures for critical operations like complaint handling and product release, and insufficient training and validation protocols. These issues indicate a systemic failure to ensure product quality and compliance.
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ID · 8beacf8b-36a8-4444-9036-9f38741c716a