Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-27.
At a glance
Inspections
10
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Jun 2024 – 27 Jun 2024 | Foods & Cosmetics | Clean | |
| 12 Jun 2024 | Foods & Cosmetics | 483 | On file |
| 18 Feb 2021 | Foods & Cosmetics | Clean | |
| 9 Jul 2019 – 22 Jul 2019 | Foods & Cosmetics | 483 | View 483 → |
| 13 Aug 2018 | Foods & Cosmetics | 483 | On file |
| 2 Feb 2017 | Foods & Cosmetics | 483 | On file |
| 7 Jul 2014 | Foods & Cosmetics | Clean | |
| 15 Feb 2012 | Not recorded | Clean | |
| 15 Aug 2008 | Not recorded | Clean | |
| 5 Jun 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
State Agency7 insp.
Alicia Frees1 insp.
Kristi B Panzer1 insp.
Melissa N Wilson1 insp.
Melissa N Simanton1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| 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 site report
Get the verbatim findings behind Premium Waters, Inc.'s 4 Form 483s
Recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat