Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-09-25.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Sep 2019 – 25 Sep 2019 | Human Drugs | Clean | |
| 25 Jun 2019 – 27 Jun 2019 | Human Drugs | Clean | |
| 15 Feb 2016 – 17 Feb 2016 | Human Drugs | 483 | View 483 → |
| 5 Mar 2013 – 7 Mar 2013 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Feb 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Meisha R Sampson, Meisha R Waters
17 Feb 2016
21 CFR 211.67(b)
Written procedures fail to include
Cited by Meisha R Sampson, Meisha R Waters
17 Feb 2016
21 CFR 211.67(c)
Cleaning/maintenance records not kept
Cited by Meisha R Sampson, Meisha R Waters
Investigators
FDA investigators tied to this site in the record.
Guerlain Ulysse1 insp.
MRA McCulloughJ1 insp.
Meisha R Sampson1 insp.
Meisha R Waters1 insp.
Charles Cote1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(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)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Wickham Micro Limited's 1 Form 483
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