Overview
- 12 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-09-10.
At a glance
Inspections
12
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Sep 2019 – 10 Sep 2019 | Human Drugs | 483 | On file |
| 6 Apr 2017 – 13 Apr 2017 | Human Drugs | Clean | |
| 1 Jun 2015 – 10 Jun 2015 | Human Drugs | 483 | View 483 → |
| 18 Feb 2013 – 26 Feb 2013 | Human Drugs | 483 | View 483 → |
| 12 May 2011 | Not recorded | 483 | On file |
| 8 Sep 2009 | Not recorded | WL | View 483 → |
| 6 Apr 2006 | Not recorded | Clean | |
| 9 Mar 2004 | Not recorded | Clean | |
| 1 Jul 2003 | Not recorded | Clean | |
| 15 Mar 2002 | Not recorded | Clean | |
| 30 Nov 2001 | Not recorded | Clean | |
| 11 May 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Jun 2015
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Katherine E Jacobitz, Xiaokuang Lai
10 Jun 2015
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Katherine E Jacobitz, Xiaokuang Lai
26 Feb 2013
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Julianne C Mccullough, Barbara D Paul
26 Feb 2013
21 CFR 211.65(a)
Equipment construction - reactive surfaces
Cited by Julianne C Mccullough, Barbara D Paul
Investigators
FDA investigators tied to this site in the record.
Zhong Li1 insp.
Zachery L Miller1 insp.
Marie B Buen-Bigornia1 insp.
Katherine E Jacobitz1 insp.
Xiaokuang Lai1 insp.
Julianne C Mccullough1 insp.
Barbara D Paul1 insp.
Caryn M Mcnab1 insp.
Jose A Cruz Gonzalez1 insp.
Parul M Patel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fareva Pau'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