Overview
- 14 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
10 Aug 2018
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Carrie L Doupnik, Karen A Spencer, Christopher M Henderson, Lillian C Hsu
10 Aug 2018
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Carrie L Doupnik, Karen A Spencer, Christopher M Henderson, Lillian C Hsu
10 Aug 2018
21 CFR 117.145(b)
Process Controls Monitoring Frequency
Cited by Carrie L Doupnik, Karen A Spencer, Christopher M Henderson, Lillian C Hsu
10 Aug 2018
21 CFR 117.145(b)
Process Controls Monitoring Frequency
Cited by Carrie L Doupnik, Karen A Spencer, Christopher M Henderson, Lillian C Hsu
10 Aug 2018
21 CFR 117.150(a)(1)
Process Controls Corrective Action Proced: Estab Implement
Cited by Carrie L Doupnik, Karen A Spencer, Christopher M Henderson, Lillian C Hsu
Inspected site
FNFamarco Newco LLCVirginia Beach, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.145(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.150(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.165(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.35(c) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 14 observations
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