Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
4 Apr 2013
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Chad J Whitwell, Bruce H Mccullough
4 Apr 2013
21 CFR 211.84(d)(1)
Component identity verification
Cited by Chad J Whitwell, Bruce H Mccullough
4 Apr 2013
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Chad J Whitwell, Bruce H Mccullough
4 Apr 2013
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Chad J Whitwell, Bruce H Mccullough
Inspected site
FLFinish Line Horse Products Inc.Bensenville, United States
Inspection team
BHBruce H Mccullough
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 observations
The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere