Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-11-20.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Nov 2017 – 20 Nov 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Oct 2016 – 13 Oct 2016 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Nov 2017
21 CFR 211.80(a)
Procedures To Be in Writing
Cited by Jose O Hernandez, Ronald Ifraimov, Marion Michaelis
20 Nov 2017
21 CFR 211.80(a)
Procedures To Be in Writing
Cited by Jose O Hernandez, Ronald Ifraimov, Marion Michaelis
20 Nov 2017
21 CFR 803.17
Lack of Written MDR Procedures
Cited by Jose O Hernandez, Ronald Ifraimov, Marion Michaelis
20 Nov 2017
21 CFR 803.17
Lack of Written MDR Procedures
Cited by Jose O Hernandez, Ronald Ifraimov, Marion Michaelis
20 Nov 2017
21 CFR 820.100(b)
Documentation
Cited by Jose O Hernandez, Ronald Ifraimov, Marion Michaelis
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Shalon Chemical Industries Ltd.'s 2 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat