Finish Line Horse Products Inc.
Form 483 issued February 16, 2023 · Bensenville, Illinois
- Inspection
- Feb 13 – Feb 16, 2023
- Observations
- 9
- Pages
- 6
- FEI number
- 1420708
In short: On February 16, 2023, FDA issued a Form 483 with 9 observations to Finish Line Horse Products Inc. in Bensenville, Illinois (FEI 1420708) after an inspection that ran Feb 13 – Feb 16, 2023. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 6 of 9 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacture, processing, packing or holding of drug products are not free of…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
This inspection in context
Questions about this 483
What did FDA find at Finish Line Horse Products Inc.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Finish Line Horse Products Inc. inspected by FDA?
The inspection ran Feb 13 – Feb 16, 2023, and the Form 483 is dated February 16, 2023.
How do I get the full Form 483 for Finish Line Horse 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.