Overview
- 10 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-10-17.
At a glance
Inspections
10
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Oct 2018 – 17 Oct 2018 | Animal Drugs & Feeds | 483 | View 483 → |
| 7 Nov 2016 – 10 Nov 2016 | Human Drugs | 483 | View 483 → |
| 3 Jun 2015 – 8 Jun 2015 | Human Drugs | Clean | |
| 7 Jan 2014 – 9 Jan 2014 | Human Drugs | Clean | |
| 17 Nov 2011 | Not recorded | 483 | View 483 → |
| 26 Aug 2010 | Not recorded | WL | View 483 → |
| 30 Jul 2009 | Not recorded | 483 | On file |
| 6 Nov 2006 | Not recorded | Clean | |
| 19 Sep 2005 | Not recorded | Clean | |
| 17 Nov 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Oct 2018
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Uttaniti Limchumroon, Nayan J Patel
17 Oct 2018
21 CFR 211.166(a)
Lack of written stability program
Cited by Uttaniti Limchumroon, Nayan J Patel
17 Oct 2018
21 CFR 211.192
No written record of investigation
Cited by Uttaniti Limchumroon, Nayan J Patel
17 Oct 2018
21 CFR 211.22(a)
Approve or reject components, products
Cited by Uttaniti Limchumroon, Nayan J Patel
17 Oct 2018
21 CFR 211.68(b)
Computer control of master formula records
Cited by Uttaniti Limchumroon, Nayan J Patel
Investigators
FDA investigators tied to this site in the record.
Marcus F Yambot3 insp.
Jennifer M Gogley2 insp.
John A Gonzalez2 insp.
Uttaniti Limchumroon1 insp.
Nayan J Patel1 insp.
Nicholas L Hunt1 insp.
James A Barreto1 insp.
Thao T Kwan1 insp.
Binh T Nguyen1 insp.
Caryn M Mcnab1 insp.
Jamie M Du1 insp.
Pal S Mayasandra1 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 | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 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 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | 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 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cephazone Pharma, LLC's 5 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