Horizon Tool Inc.
Form 483 issued January 16, 2025 · GREENSBORO, North Carolina
- Inspection
- Jan 14 – Jan 16, 2025
- Observations
- 5
- Pages
- 5
- FEI number
- 3016555297
In short: On January 16, 2025, FDA issued a Form 483 with 5 observations to Horizon Tool Inc. in GREENSBORO, North Carolina (FEI 3016555297) after an inspection that ran Jan 14 – Jan 16, 2025. Most observations concern production and packaging & labeling; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
3 of 5 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
In-process materials are not tested for identity, strength, quality and purity and approved or rejected by…
- 04
Packaged and labeled products are not examined during finishing operations to provide assurance that containers and…
This inspection in context
Questions about this 483
What did FDA find at Horizon Tool Inc.?
FDA listed 5 observations on this Form 483, mostly about production, packaging & labeling and quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
When was Horizon Tool Inc. inspected by FDA?
The inspection ran Jan 14 – Jan 16, 2025, and the Form 483 is dated January 16, 2025.
How do I get the full Form 483 for Horizon Tool 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.