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.
2 May 2024
21 CFR 1271.195(a)
Adequate control, proper conditions
Cited by Leslie W Gilbert, Tammara A Stephens
2 May 2024
21 CFR 1271.195(a)(1)
Temperature and humidity controls
Cited by Leslie W Gilbert, Tammara A Stephens
2 May 2024
21 CFR 1271.195(a)(3)
Aseptic processing---cleaning, disinfecting
Cited by Leslie W Gilbert, Tammara A Stephens
2 May 2024
21 CFR 1271.195(c)
Monitoring-microorganisms where appropriate
Cited by Leslie W Gilbert, Tammara A Stephens
Inspected site
NANorth American Science Associates, LLCMarietta, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.195(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.210(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.250(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
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