Overview
- 12 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
27 Jul 2021
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Jacqueline S Warner
27 Jul 2021
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Jacqueline S Warner
Inspected site
ASA.M. Surgical, Inc.Smithtown, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.186 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 12 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