Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
8 May 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Brentley S Collins, Laurel A Beer, Brentley S Pittman
8 May 2024
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Brentley S Collins, Laurel A Beer, Brentley S Pittman
8 May 2024
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Brentley S Collins, Laurel A Beer, Brentley S Pittman
8 May 2024
21 CFR 211.84(d)(3)
Establish reliability of supplier's C of A
Cited by Brentley S Collins, Laurel A Beer, Brentley S Pittman
Inspected site
ASAfton Scientific, LLCCharlottesville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | 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 4 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