Overview
- 12 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-30.
At a glance
Inspections
12
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Aug 2024 – 30 Aug 2024 | Human Drugs | 483 | On file |
| 3 Dec 2019 – 10 Dec 2019 | Human Drugs | Clean | |
| 13 May 2019 – 24 May 2019 | Human Drugs | Clean | |
| 27 Feb 2017 – 3 Mar 2017 | Human Drugs | 483 | On file |
| 12 Jan 2015 – 16 Jan 2015 | Human Drugs | 483 | On file |
| 3 Aug 2012 | Not recorded | Clean | |
| 22 Oct 2010 | Not recorded | 483 | On file |
| 19 Jun 2009 | Not recorded | Clean | |
| 22 Jan 2007 | Not recorded | Clean | |
| 25 Jan 2005 | Not recorded | Clean | |
| 5 Jun 2003 | Not recorded | Clean | |
| 20 Mar 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Aug 2024
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Linda Thai, Gunneet Kaur
30 Aug 2024
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Linda Thai, Gunneet Kaur
3 Mar 2017
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Tenzin Jangchup, Haroon Vohra, Zachery L Miller
3 Mar 2017
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Tenzin Jangchup, Haroon Vohra, Zachery L Miller
16 Jan 2015
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Linda F Murphy, Erika V Butler, Jamie L Dion
Investigators
FDA investigators tied to this site in the record.
Zachery L Miller2 insp.
Erika V Butler2 insp.
Linda Thai1 insp.
Gunneet Kaur1 insp.
Teresa I Navas1 insp.
John A Gonzalez1 insp.
Tenzin Jangchup1 insp.
Haroon Vohra1 insp.
Linda F Murphy1 insp.
Jamie L Dion1 insp.
Linda M Cherry1 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 | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Anesta LLC's 4 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