Finish Line Horse Products Inc.
Form 483 issued September 16, 2022 · Bensenville, Illinois
- Inspection
- Sep 2 – Sep 16, 2022
- Investigator
- Peng Zhou
- Observations
- 5
- Pages
- 5
- FEI number
- 1420708
In short: On September 16, 2022, FDA issued a Form 483 with 5 observations to Finish Line Horse Products Inc. in Bensenville, Illinois (FEI 1420708) after an inspection that ran Sep 2 – Sep 16, 2022. The investigator was Peng Zhou. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 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
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Strict control is not exercised over labeling issued for use in drug product…
This inspection in context
Peng Zhou
15 documents · 2019–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmFinish Line Horse Products Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.56(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Finish Line Horse Products Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Finish Line Horse Products Inc.?
Peng Zhou is named on this Form 483, for the inspection of Sep 2 – Sep 16, 2022. Each investigator has a profile showing what they cite most.
When was Finish Line Horse Products Inc. inspected by FDA?
The inspection ran Sep 2 – Sep 16, 2022, and the Form 483 is dated September 16, 2022.
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.