# FDA 483 - Hit Promotional Products Inc. - August 02, 2019

Source: https://www.globalkeysolutions.net/records/483/hit-promotional-products-inc/8beacf8b-36a8-4444-9036-9f38741c716a

> FDA 483 for Hit Promotional Products Inc. on August 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hit Promotional Products Inc.
- Inspection Date: 2019-08-02
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.globalkeysolutions.net/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.globalkeysolutions.net/companies/hit-promotional-products-inc/3d9863c8-7b59-47f4-895d-0059bc573d0b

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6