Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-07-19.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jul 2017 – 19 Jul 2017 | Human Drugs | 483 | View 483 → |
| 21 May 2014 – 30 May 2014 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Jul 2017
21 CFR 211.165(a)
Testing and release for distribution
Cited by Kristin M Abaonza, Eileen A Liu, Rumany C Penn
19 Jul 2017
21 CFR 211.165(f)
Failing drug products not rejected
Cited by Kristin M Abaonza, Eileen A Liu, Rumany C Penn
19 Jul 2017
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Kristin M Abaonza, Eileen A Liu, Rumany C Penn
30 May 2014
21 CFR 211.56(c)
Written procedures lacking for use of pesticides etc.
Cited by Ashar P Parikh, Jennifer H Rhyu
Investigators
FDA investigators tied to this site in the record.
Kristin M Abaonza1 insp.
Eileen A Liu1 insp.
Rumany C Penn1 insp.
Ashar P Parikh1 insp.
Jennifer H Rhyu1 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 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind One Way Drug, LLC's 2 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