Overview
- 22 public-safe observations are available for this inspection.
- 11 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 Jul 2021
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Abby L Mozeke-Baker, Decarlos A Gomez
28 Jul 2021
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Abby L Mozeke-Baker, Decarlos A Gomez
28 Jul 2021
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Abby L Mozeke-Baker, Decarlos A Gomez
28 Jul 2021
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Abby L Mozeke-Baker, Decarlos A Gomez
28 Jul 2021
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Abby L Mozeke-Baker, Decarlos A Gomez
Inspected site
RARe-Gen Active Lab IncIrving, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 22 observations
The source PDF, 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