Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-28.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Jun 2023 – 28 Jun 2023 | Human Drugs | 483 | View 483 → |
| 21 Sep 2021 – 4 Nov 2021 | Human Drugs | 483 | View 483 → |
| 3 Jun 2019 – 7 Jun 2019 | Human Drugs | Clean | |
| 27 Feb 2017 – 17 Mar 2017 | Human Drugs | 483 | View 483 → |
| 25 Jan 2016 – 28 Jan 2016 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Jun 2023
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Edmund F Mrak, Pushpa S Jayasekara
28 Jun 2023
21 CFR 211.63
Equipment Design, Size and Location
Cited by Edmund F Mrak, Pushpa S Jayasekara
28 Jun 2023
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Edmund F Mrak, Pushpa S Jayasekara
Investigators
FDA investigators tied to this site in the record.
Edmund F Mrak2 insp.
Chad N Thompson2 insp.
Pushpa S Jayasekara1 insp.
Lori M Newman1 insp.
Russell J Glapion1 insp.
Rachael A Moliver1 insp.
Juan R Jimenez Garcia1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(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)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(5) | 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 |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SterRx, LLC'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