Overview
- 15 public-safe observations are available for this inspection.
- 8 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.
5 Jan 2017
21 CFR 111.535(b)(1)
Records - returned dietary supplement: written procedures
Cited by Joseph Tibay
5 Jan 2017
21 CFR 111.570(b)(1)
Written procedures - product complaint; review, investigate
Cited by Joseph Tibay
5 Jan 2017
21 CFR 111.570(b)(1)
Written procedures - product complaint; review, investigate
Cited by Joseph Tibay
Inspected site
KSKwok Shing, Inc.San Francisco, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.20(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(8) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.55 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 15 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