Overview
- 10 public-safe observations are available for this inspection.
- 10 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 Mar 2017
21 CFR 111.105
Ensure quality; package, labeled, master record
Cited by Siobhan A Gallagher, Nympha V Florendo
24 Mar 2017
21 CFR 111.155(c)(1)
Components - representative samples
Cited by Siobhan A Gallagher, Nympha V Florendo
24 Mar 2017
21 CFR 111.205(a)
Master manufacturing record - each batch
Cited by Siobhan A Gallagher, Nympha V Florendo
24 Mar 2017
21 CFR 111.475(b)(1)
Written procedures - holding; distributing
Cited by Siobhan A Gallagher, Nympha V Florendo
Inspected site
PCPrestige Chinese Teas Co. Inc.Burlingame, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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