Overview
- 8 public-safe observations are available for this inspection.
- 4 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.
24 Jun 2019
21 CFR 117.135(a)(1)
Preventive Controls - Identify
Cited by David A Gonzalez, Laura L Van Wagenen
24 Jun 2019
21 CFR 117.145(a)
Allergen Controls Monitoring Proced: Establish Implement
Cited by David A Gonzalez, Laura L Van Wagenen
24 Jun 2019
21 CFR 117.35(a)
Sanitary Operations - Plant Sanitation
Cited by David A Gonzalez, Laura L Van Wagenen
24 Jun 2019
21 CFR 117.415(a)(2)
Supply-Chain Appropriate Verification Activities
Cited by David A Gonzalez, Laura L Van Wagenen
24 Jun 2019
21 CFR 117.135(a)(1)
Preventive Controls - Identify
Cited by David A Gonzalez, Laura L Van Wagenen
Inspected site
BMBlue Moose of Boulder, LLCLafayette, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.415(a)(2) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, 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