Hit Promotional Products Inc.

Form 483 issued January 28, 2026 · Saint Petersburg, Florida

Inspection
Jan 26 – Jan 28, 2026
Observations
5
Pages
4
FEI number
1000352706

In short: On January 28, 2026, FDA issued a Form 483 with 5 observations to Hit Promotional Products Inc. in Saint Petersburg, Florida (FEI 1000352706) after an inspection that ran Jan 26 – Jan 28, 2026. The investigators were Kayla V. Sprague and Michael Z. Weigman. Most observations concern quality system and production.

At a glance

Observations span 4 systems, led by quality system.

Quality system1
Production1
Laboratory controls1
Materials1
Other1

What FDA observed

Preview: the opening words of each observation
  1. 01

    The responsibilities and procedures applicable to the quality control unit are not in…

  2. 02

    Your firm failed to establish adequate written procedures for production and process controls designed to assure…

  3. 03

    There is no written testing program designed to assess the stability…

  4. 04

    There is no documentation of the examination and review of labels and labeling for…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Hit Promotional Products Inc.?

FDA listed 5 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.

Who inspected Hit Promotional Products Inc.?

Kayla V. Sprague and Michael Z. Weigman are named on this Form 483, for the inspection of Jan 26 – Jan 28, 2026. Each investigator has a profile showing what they cite most.

When was Hit Promotional Products Inc. inspected by FDA?

The inspection ran Jan 26 – Jan 28, 2026, and the Form 483 is dated January 28, 2026.

How do I get the full Form 483 for Hit Promotional Products Inc.?

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