Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Sanitation monitoring
Cited by Cornelius Brown, Andrea L Williams-Jones, Valeria A Moore, Nina D Patel, Betsy A Newcomer
Corrective action plan
Cited by Cornelius Brown, Andrea L Williams-Jones, Valeria A Moore, Nina D Patel, Betsy A Newcomer
Records system
Cited by Cornelius Brown, Andrea L Williams-Jones, Valeria A Moore, Nina D Patel, Betsy A Newcomer
Verification procedures - none/frequency
Cited by Cornelius Brown, Andrea L Williams-Jones, Valeria A Moore, Nina D Patel, Betsy A Newcomer
Signed and dated
Cited by Cornelius Brown, Andrea L Williams-Jones, Valeria A Moore, Nina D Patel, Betsy A Newcomer
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(d) | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 observations
The source PDF and 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