# FDA 483 - Hit Promotional Products Inc. - January 28, 2026

Source: https://www.keypedia.com/records/483/hit-promotional-products-inc/4274ada9-27dc-4af6-91b3-61296a3790b8

> FDA 483 for Hit Promotional Products Inc. on January 28, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hit Promotional Products Inc.
- Inspection Date: 2026-01-28
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Hit Promotional Products Inc. in Saint Petersburg, FL, an OTC Human Drug Labeler, was cited for significant deficiencies in its quality control unit, production and process controls, and facility conditions. The inspection revealed a lack of written procedures for critical operations like label control, complaint handling, deviation management, and product recalls, as well as inadequate stability testing and environmental controls in the warehouse. These issues indicate a systemic failure to ensure the identity, strength, purity, and quality of their OTC drug products.

## Related Documents

- [483 - 2019-08-02](https://www.keypedia.com/records/483/hit-promotional-products-inc/8beacf8b-36a8-4444-9036-9f38741c716a)
- [483 - 2026-01-28](https://www.keypedia.com/records/483/hit-promotional-products-inc/a7732b25-7148-4ebd-a8fb-2984888feedd)

## Related Officers

- [Michael Z. Weigman](https://www.keypedia.com/people/michael-z-weigman/fcf79bb1-87cc-476c-a1af-758ef0126ee9)
- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)

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

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