Overview
- 7 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
9 Jul 2019
21 CFR 114.100(b)
Maintenance of processing and production records
Cited by Edith M Gonzalez, Rachel Gomez, Daniel C Geffin
9 Jul 2019
21 CFR 114.80(a)(4)
Container testing
Cited by Edith M Gonzalez, Rachel Gomez, Daniel C Geffin
9 Jul 2019
21 CFR 117.40
Equipment and Utensils - Design and Maintenance
Cited by Edith M Gonzalez, Rachel Gomez, Daniel C Geffin
9 Jul 2019
21 CFR 114.100(b)
Processing and production - required information
Cited by Edith M Gonzalez, Rachel Gomez, Daniel C Geffin
Inspected site
LALIANYUNGANG AIKANG FOOD CO., LTDLianyungang City, China
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 114.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 114.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.89 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40 | 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