Overview
- 21 public-safe observations are available for this inspection.
- 7 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.
19 Sep 2023
21 CFR 1002.30(a)(2)
Basis for selecting methods, devices, procedures
Cited by Matthew D Schnittker
19 Sep 2023
21 CFR 1002.30(a)(2)
Basis for selecting methods, devices, procedures
Cited by Matthew D Schnittker
19 Sep 2023
21 CFR 1002.30(a)(2)
Basis for selecting methods, devices, procedures
Cited by Matthew D Schnittker
19 Sep 2023
21 CFR 1020.30(h)(2)(i)
Tube housing assemblies (leakage technique factors)
Cited by Matthew D Schnittker
19 Sep 2023
21 CFR 1020.30(h)(2)(i)
Tube housing assemblies (leakage technique factors)
Cited by Matthew D Schnittker
Inspected site
FSFirst Source, Inc.Rochester, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1002.30(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1020.30(h)(2)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1020.30(h)(2)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
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 21 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