Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
4 Dec 2015
21 CFR 211.160(b)(4)
Instruments, apparatus, et. al. not meeting specs
Cited by Eric L Dong, Deborah J Parris
4 Dec 2015
21 CFR 211.166(a)(4)
Testing in same container - closure system
Cited by Eric L Dong, Deborah J Parris
4 Dec 2015
21 CFR 211.182
Personnel dating/signing equipment log
Cited by Eric L Dong, Deborah J Parris
4 Dec 2015
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Eric L Dong, Deborah J Parris
4 Dec 2015
21 CFR 211.65(a)
Equipment construction - reactive surfaces
Cited by Eric L Dong, Deborah J Parris
Inspected site
FAFoshan Aqua Gel Biotech Co., Ltd.Foshan, China
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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