Overview
- 12 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-09.
At a glance
Inspections
12
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 May 2023 – 9 Jun 2023 | Foods & Cosmetics | 483 | View 483 → |
| 12 Dec 2022 – 6 Feb 2023 | Human Drugs | 483 | On file |
| 17 Aug 2021 – 10 Sep 2021 | Human Drugs | 483 | View 483 → |
| 17 Aug 2018 – 7 Sep 2018 | Human Drugs | WL | View 483 → |
| 15 Sep 2016 – 29 Sep 2016 | Human Drugs | 483 | View 483 → |
| 17 Apr 2013 – 26 Apr 2013 | Human Drugs | 483 | View 483 → |
| 22 Jul 2010 | Not recorded | 483 | View 483 → |
| 25 Feb 2009 | Not recorded | 483 | On file |
| 7 Dec 2007 | Not recorded | Clean | |
| 10 Apr 2006 | Not recorded | Clean | |
| 2 Aug 2004 | Not recorded | Clean | |
| 8 Aug 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Sep 2021
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Yvins Dezan, Jonah S Ufferfilge
10 Sep 2021
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Yvins Dezan, Jonah S Ufferfilge
10 Sep 2021
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Yvins Dezan, Jonah S Ufferfilge
Investigators
FDA investigators tied to this site in the record.
Jonah S Ufferfilge2 insp.
Maya M Davis2 insp.
Mark R Mcclain2 insp.
Kimberly M White1 insp.
Yvins Dezan1 insp.
Helen B Ricalde1 insp.
Nealie C Newberger1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | 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 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 1x |
| FDCA 601(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ecometics, Inc.'s 8 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