Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
15 Jun 2012
21 CFR 111.35(b)(2)
Document-equipment date of use, maintain, clean, sanitize
Cited by Rachel Peters
15 Jun 2012
21 CFR 111.83(b)(1)
Reserve sample container-closure contamination,deterioration
Cited by Rachel Peters
Inspected site
ESExcelVite Sdn. Bhd.Chemor, Malaysia
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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