Overview
- 11 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
18 Sep 2009
21 CFR 110.10(b)(9)
Precautions against contamination--micro, foreign substances
Cited by Terrance P Nguyen, Lin Liu, Pamela Y Lee, Gordon Chu
18 Sep 2009
21 CFR 110.20(b)(1)
Sufficient space
Cited by Terrance P Nguyen, Lin Liu, Pamela Y Lee, Gordon Chu
18 Sep 2009
21 CFR 110.20(b)(6)
Fans/air blowing equipment
Cited by Terrance P Nguyen, Lin Liu, Pamela Y Lee, Gordon Chu
18 Sep 2009
21 CFR 110.20(b)(7)
Screening
Cited by Terrance P Nguyen, Lin Liu, Pamela Y Lee, Gordon Chu
18 Sep 2009
21 CFR 110.80(a)(5)
Holding in bulk or suitable containers
Cited by Terrance P Nguyen, Lin Liu, Pamela Y Lee, Gordon Chu
Inspected site
PEPacific Exchange Distributors, LLCGardena, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.80(a)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.12(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.12(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.9(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 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