Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
20 Apr 2016
21 CFR 111.260(c)
Batch record - date, time; maintenance
Cited by Elodie X Tong-Lin, Kacie M Crowther, Edna J Hidalgo
20 Apr 2016
21 CFR 111.365(a)
Conditions, controls -protect; microorganisms, contamination
Cited by Elodie X Tong-Lin, Kacie M Crowther, Edna J Hidalgo
20 Apr 2016
21 CFR 111.560(b)
Quality control, review, approve; investigate, follow-up
Cited by Elodie X Tong-Lin, Kacie M Crowther, Edna J Hidalgo
20 Apr 2016
21 CFR 111.15(k)
Sanitation supervisors - qualified
Cited by Elodie X Tong-Lin, Kacie M Crowther, Edna J Hidalgo
20 Apr 2016
21 CFR 111.205(a)
Master manufacturing record - each batch
Cited by Elodie X Tong-Lin, Kacie M Crowther, Edna J Hidalgo
Inspected site
TEThreshold Enterprises, Ltd.Scotts Valley, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.15(k) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
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