Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-06-15.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Jun 2017 – 15 Jun 2017 | Human Drugs | 483 | View 483 → |
| 23 Jun 2016 – 27 Jun 2016 | Human Drugs | 483 | On file |
| 26 Jul 2013 | Foods & Cosmetics | Clean | |
| 10 Aug 2011 | Not recorded | Clean | |
| 15 Jul 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jun 2017
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Nancy E Byerly
15 Jun 2017
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Nancy E Byerly
15 Jun 2017
21 CFR 111.475(a)
Records - holding, distribution: readily available
Cited by Nancy E Byerly
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.180(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.475(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(f) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Esteem Products LTD's 2 Form 483s
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