Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
8 Jul 2010
21 CFR 110.40(c)
Non food-contact equipment in processing area
Cited by Osama A Khatib, Rupa Pradhan
8 Jul 2010
21 CFR 110.40(f)
Q.C. instrument accuracy, maintenance
Cited by Osama A Khatib, Rupa Pradhan
8 Jul 2010
21 CFR 114.100(a)
Raw materials, packaging, finished product
Cited by Osama A Khatib, Rupa Pradhan
Inspected site
RCRohtstein Corp.Woburn, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.100(a) | 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