Overview
- 3 public-safe observations are available for this inspection.
- 1 structured CFR citation is represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Aug 2022
21 CFR 117.135(a)(1)
Allergen preventive controls - Identify (Written)
Cited by Michelle L Jones
5 Aug 2022
21 CFR 117.135(a)(1)
Allergen preventive controls - Identify (Written)
Cited by Michelle L Jones
5 Aug 2022
21 CFR 117.135(a)(1)
Allergen preventive controls - Identify (Written)
Cited by Michelle L Jones
Inspected site
PBPowered By FTGU LLC.Lincolnton, 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 | 3x |
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 3 observations
The source PDF, 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