Hit Promotional Products Inc.
Form 483 issued January 28, 2026 · Saint Petersburg, Florida
- Inspection
- Jan 26 – Jan 28, 2026
- Investigators
- Kayla V. Sprague· Michael Z. Weigman
- 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.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
There is no written testing program designed to assess the stability…
- 04
There is no documentation of the examination and review of labels and labeling for…
This inspection in context
Kayla V. Sprague
17 documents · 2020–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Florida.
The firmHit Promotional Products Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
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.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.