Overview
- 18 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
20 Jul 2017
21 CFR 111.127(d)
QC operations - packaged, labeled; specifications
Cited by Helen J Hamaoka
20 Jul 2017
21 CFR 111.127(d)
QC operations - packaged, labeled; specifications
Cited by Helen J Hamaoka
20 Jul 2017
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Helen J Hamaoka
20 Jul 2017
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Helen J Hamaoka
Inspected site
TLTriple Leaf Tea, Inc.Burlingame, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.127(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.155(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.23(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 18 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