Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-03-31.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Mar 2017 – 31 Mar 2017 | Human Drugs | WL | View 483 → |
| 23 Feb 2016 – 14 Mar 2016 | Human Drugs | WL | View 483 → |
| 23 Jun 2014 – 2 Jul 2014 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Mar 2017
21 CFR 211.198(b)(2)
Complaint Investigation/Follow-Up Findings
Cited by Roger F Zabinski, Theresa Kirkham
31 Mar 2017
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Roger F Zabinski, Theresa Kirkham
14 Mar 2016
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Saied A Asbagh, Darren S Brown, Binh T Nguyen
14 Mar 2016
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Saied A Asbagh, Darren S Brown, Binh T Nguyen
Investigators
FDA investigators tied to this site in the record.
Roger F Zabinski1 insp.
Theresa Kirkham1 insp.
Saied A Asbagh1 insp.
Darren S Brown1 insp.
Binh T Nguyen1 insp.
Jennifer M Gogley1 insp.
Caryn M Mcnab1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ImprimisRx CA, Inc., dba ImprimisRx's 3 Form 483s
Source PDFs, 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