Overview
- 5 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
22 Jul 2019
21 CFR 117.40(f)
Instruments and Controls
Cited by Kristi B Panzer, Melissa N Wilson, Melissa N Simanton
22 Jul 2019
21 CFR 129.80(a)
Effective treatment - product water
Cited by Kristi B Panzer, Melissa N Wilson, Melissa N Simanton
22 Jul 2019
21 CFR 129.80(a)
Records - equipment inspection
Cited by Kristi B Panzer, Melissa N Wilson, Melissa N Simanton
22 Jul 2019
21 CFR 129.80(f)
Bacteriological swab, rinse count - containers, closures (S)
Cited by Kristi B Panzer, Melissa N Wilson, Melissa N Simanton
22 Jul 2019
21 CFR 129.80(g)(1)
Representative samples - bottled water
Cited by Kristi B Panzer, Melissa N Wilson, Melissa N Simanton
Inspected site
PWPremium Waters, Inc.Riverside, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 129.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 129.80(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 129.80(g)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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