Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-18.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jan 2024 – 18 Jan 2024 | Human Drugs | Clean | |
| 30 Mar 2016 – 8 Apr 2016 | Human Drugs | 483 | View 483 → |
| 15 May 2013 – 18 Jun 2013 | Human Drugs | 483 | View 483 → |
| 16 Aug 2010 | Not recorded | 483 | View 483 → |
| 26 Aug 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Apr 2016
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Qin Xu, Steven P Donald
8 Apr 2016
21 CFR 211.68(a)
Written calibration / inspection records not kept
Cited by Qin Xu, Steven P Donald
8 Apr 2016
21 CFR 211.68(b)
Written record not kept of program and validation data
Cited by Qin Xu, Steven P Donald
Investigators
FDA investigators tied to this site in the record.
Tekalign Wondimu1 insp.
Pamela N Agaba1 insp.
Johnny D Nwankwo1 insp.
Azeezat M Lawal1 insp.
Qin Xu1 insp.
Steven P Donald1 insp.
Nebil A Oumer1 insp.
Rachel C Harrington1 insp.
Edward P Potter1 insp.
Stacey A Priest1 insp.
Joseph W Matthews1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 4 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