Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
15 Aug 2019
21 CFR 117.135(a)(1)
Preventive Controls - Identify
Cited by Janet B Gray, Keri U Walker, Christina H Owens
15 Aug 2019
21 CFR 117.145(a)
Allergen Controls Monitoring Proced: Establish Implement
Cited by Janet B Gray, Keri U Walker, Christina H Owens
15 Aug 2019
21 CFR 117.20(b)
Plant Construction and Design
Cited by Janet B Gray, Keri U Walker, Christina H Owens
15 Aug 2019
21 CFR 117.93
Storage and Transportation
Cited by Janet B Gray, Keri U Walker, Christina H Owens
15 Aug 2019
21 CFR 117.135(a)(1)
Preventive Controls - Identify
Cited by Janet B Gray, Keri U Walker, Christina H Owens
Inspected site
MWMars Wrigley Confectionery US, LLCAlbany, 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 117.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.93 | 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