Overview
- 19 public-safe observations are available for this inspection.
- 18 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
21 Jul 2017
21 CFR 111.180(b)(2)
Records - receiving; components, packaging, labels, products
Cited by Kathryn A Guardiola, Martin R Vowell, Jacob A Clark, Kathryn G Brown
21 Jul 2017
21 CFR 111.180(b)(3)
Documentation - components
Cited by Kathryn A Guardiola, Martin R Vowell, Jacob A Clark, Kathryn G Brown
21 Jul 2017
21 CFR 111.210(h)(3)(ii)(B)
Components; add, verify
Cited by Kathryn A Guardiola, Martin R Vowell, Jacob A Clark, Kathryn G Brown
21 Jul 2017
21 CFR 111.210(h)(5)
Corrective action plans
Cited by Kathryn A Guardiola, Martin R Vowell, Jacob A Clark, Kathryn G Brown
21 Jul 2017
21 CFR 111.260(j)(1)
Batch record - date, each step
Cited by Kathryn A Guardiola, Martin R Vowell, Jacob A Clark, Kathryn G Brown
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 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.155(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(3)(ii)(B) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(B) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.77(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.87 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 19 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