Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
5 Mar 2020
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Christopher M Jenner, Carrie A Hughes
5 Mar 2020
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Christopher M Jenner, Carrie A Hughes
5 Mar 2020
21 CFR 211.166(a)
Lack of written stability program
Cited by Christopher M Jenner, Carrie A Hughes
5 Mar 2020
21 CFR 211.198(a)
Reporting of adverse drug experience to FDA
Cited by Christopher M Jenner, Carrie A Hughes
5 Mar 2020
21 CFR 211.22(a)
Lack of quality control unit
Cited by Christopher M Jenner, Carrie A Hughes
Inspected site
RLRLC Labs Inc.Phoenix, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Source document
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PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 7 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