Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-09-20.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Sep 2021 – 20 Sep 2021 | Human Drugs | 483 | View 483 → |
| 27 Nov 2017 – 7 Dec 2017 | Human Drugs | WL | View 483 → |
| 6 Mar 2013 – 14 Mar 2013 | Human Drugs | 483 | View 483 → |
| 21 Feb 2012 | Not recorded | 483 | On file |
| 23 Sep 2010 | Not recorded | Clean | |
| 24 Sep 2009 | Not recorded | 483 | View 483 → |
| 29 Jun 2009 | Not recorded | Clean | |
| 25 Sep 2007 | Not recorded | Clean | |
| 11 Mar 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Sep 2021
21 CFR 211.165(b)
Microbiological testing
Cited by Scott N Lim, Vaishali J Patel, Sherrie M La
20 Sep 2021
21 CFR 211.180(e)(2)
Items to cover on annual reviews
Cited by Scott N Lim, Vaishali J Patel, Sherrie M La
20 Sep 2021
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Scott N Lim, Vaishali J Patel, Sherrie M La
20 Sep 2021
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Scott N Lim, Vaishali J Patel, Sherrie M La
20 Sep 2021
21 CFR 211.25(a)
GMP Training Frequency
Cited by Scott N Lim, Vaishali J Patel, Sherrie M La
Investigators
FDA investigators tied to this site in the record.
Scott N Lim1 insp.
Vaishali J Patel1 insp.
Sherrie M La1 insp.
Theresa Kirkham1 insp.
Thao T Kwan1 insp.
Vashti E Bocker1 insp.
Arsen Karapetyan1 insp.
Zachary A Bogorad1 insp.
Celena Ngo1 insp.
Binh T Nguyen1 insp.
Cntrctmntr Kelley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind I Shay Cosmetics Inc.'s 5 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