Overview
- 4 public-safe observations are available for this inspection.
- 3 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.
Preventive Controls - Identify
Cited by Kunapuli T Madhusudhan, John E Aghadia, Rashonda N Rucker, Young Kim, Katelynn J Rollins, Rashard A Knight
Process Controls Monitoring Procedures: Establish Implement
Cited by Kunapuli T Madhusudhan, John E Aghadia, Rashonda N Rucker, Young Kim, Katelynn J Rollins, Rashard A Knight
Sanitation Controls Monitoring Proced: Establish Implement
Cited by Kunapuli T Madhusudhan, John E Aghadia, Rashonda N Rucker, Young Kim, Katelynn J Rollins, Rashard A Knight
Equipment and Utensils - Design and Maintenance
Cited by Kunapuli T Madhusudhan, John E Aghadia, Rashonda N Rucker, Young Kim, Katelynn J Rollins, Rashard A Knight
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 observations
The full inspection record, as Atlas holds it, 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