Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
9 Jul 2010
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Sony Mathews, Satheesh Thomas
9 Jul 2010
21 CFR 211.110(d)
Rejected in-process materials not quarantined
Cited by Sony Mathews, Satheesh Thomas
9 Jul 2010
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Sony Mathews, Satheesh Thomas
Inspected site
ESElementis SRL, Inc.Middletown, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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