Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-10-09.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2020 – 9 Oct 2020 | Human Drugs | 483 | On file |
| 4 Apr 2017 – 18 May 2017 | Human Drugs | 483 | On file |
| 29 Jun 2015 – 16 Jul 2015 | Human Drugs | WL | View 483 → |
| 25 Sep 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jul 2015
21 CFR 211.137(a)
Expiration date lacking
Cited by Zakaria I Ganiyu, Liatte Krueger, Susan M Joseph
16 Jul 2015
21 CFR 211.167(a)
Sterility/pyrogen-free testing
Cited by Zakaria I Ganiyu, Liatte Krueger, Susan M Joseph
16 Jul 2015
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Zakaria I Ganiyu, Liatte Krueger, Susan M Joseph
16 Jul 2015
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Zakaria I Ganiyu, Liatte Krueger, Susan M Joseph
16 Jul 2015
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Zakaria I Ganiyu, Liatte Krueger, Susan M Joseph
Investigators
FDA investigators tied to this site in the record.
Tonia F Bernard1 insp.
Nancy F Scheraga1 insp.
Zakaria I Ganiyu1 insp.
Liatte Krueger1 insp.
Susan M Joseph1 insp.
Li Li1 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 | 2x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | 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 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Millers of Wyckoff, Inc.'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