Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-12-14.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Dec 2018 – 14 Dec 2018 | Human Drugs | 483 | View 483 → |
| 18 Jan 2016 – 22 Jan 2016 | Human Drugs | Clean | |
| 17 Nov 2014 – 20 Nov 2014 | Human Drugs | 483 | On file |
| 17 Sep 2010 | Not recorded | 483 | On file |
| 13 Mar 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Dec 2018
21 CFR 211.68(b)
Computer control of master formula records
Cited by Truong X Nguyen, Mesfin Abdi
14 Dec 2018
21 CFR 212.20(d)
Determination need for investigation
Cited by Truong X Nguyen, Mesfin Abdi
Investigators
FDA investigators tied to this site in the record.
Truong X Nguyen1 insp.
Mesfin Abdi1 insp.
Azza Talaat1 insp.
Kathleen D Culver1 insp.
Marie F Morin1 insp.
Rebecca Parrilla1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MW ENCAP LIMITED's 4 Form 483s
Source PDFs 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