Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-06-22.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Jun 2017 – 22 Jun 2017 | Animal Drugs & Feeds | 483 | View 483 → |
| 18 Jun 2015 – 22 Jun 2015 | Animal Drugs & Feeds | 483 | View 483 → |
| 8 May 2012 | Not recorded | 483 | On file |
| 29 Apr 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Jun 2017
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Rumany C Penn, Christopher M Reed
22 Jun 2017
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Rumany C Penn, Christopher M Reed
22 Jun 2017
21 CFR 211.180(e)(2)
Items to cover on annual reviews
Cited by Rumany C Penn, Christopher M Reed
22 Jun 2017
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Rumany C Penn, Christopher M Reed
22 Jun 2017
21 CFR 211.87
Retest of approved components/containers/closures
Cited by Rumany C Penn, Christopher M Reed
Investigators
FDA investigators tied to this site in the record.
Rumany C Penn1 insp.
Christopher M Reed1 insp.
Thomas W Gordon1 insp.
Daniel J Roberts1 insp.
Alex G Kalugin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Preserve Inc.'s 3 Form 483s
Verbatim observations and 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