Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
28 Jun 2011
21 CFR 111.25(b)
Procedures - calibrating automated, mechanical equip
Cited by Michele L Forster, Rasha Bamieh
28 Jun 2011
21 CFR 111.25(c)
Procedures - equipment - cleaning, sanitizing
Cited by Michele L Forster, Rasha Bamieh
28 Jun 2011
21 CFR 111.35(b)(3)
Instruments, controls; calibrate date, reference std, method
Cited by Michele L Forster, Rasha Bamieh
28 Jun 2011
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Michele L Forster, Rasha Bamieh
28 Jun 2011
21 CFR 111.75(c)(2)
Specifications met - test, examinations; compliance
Cited by Michele L Forster, Rasha Bamieh
Inspected site
RCRXW CGMP, LLCDearborn, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.430(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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