Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 6 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Drip and condensate
Cited by Rene R Ramirez, Christopher J Hurst, Yaw O Osei, Patrice S Hall, Ronan F King, Robert T Lorenz
Cleaning and sanitizing operations
Cited by Rene R Ramirez, Christopher J Hurst, Yaw O Osei, Patrice S Hall, Ronan F King, Robert T Lorenz
Safe and adequate for use
Cited by Rene R Ramirez, Christopher J Hurst, Yaw O Osei, Patrice S Hall, Ronan F King, Robert T Lorenz
Supervisory competence
Cited by Rene R Ramirez, Christopher J Hurst, Yaw O Osei, Patrice S Hall, Ronan F King, Robert T Lorenz
Inspection, segregation, handling of raw materials
Cited by Rene R Ramirez, Christopher J Hurst, Yaw O Osei, Patrice S Hall, Ronan F King, Robert T Lorenz
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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