Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-12-07.
At a glance
Inspections
7
Form 483s
5
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Nov 2018 – 7 Dec 2018 | Human Drugs | Clean | |
| 2 Aug 2018 – 10 Aug 2018 | Human Drugs | 483 | View 483 → |
| 9 Mar 2017 – 17 Mar 2017 | Human Drugs | Clean | |
| 8 Jun 2015 – 16 Jun 2015 | Animal Drugs & Feeds | 483 | View 483 → |
| 24 Mar 2014 – 28 Mar 2014 | Human Drugs | 483 | View 483 → |
| 20 Apr 2012 | Not recorded | 483 | On file |
| 6 Nov 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Aug 2018
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Lisa B Orr, Sateesh Kum Sathigari
10 Aug 2018
21 CFR 211.110(a)
Written in-process control procedures
Cited by Lisa B Orr, Sateesh Kum Sathigari
10 Aug 2018
21 CFR 211.186(b)(9)
Manufacturing Instructions and Specifications
Cited by Lisa B Orr, Sateesh Kum Sathigari
10 Aug 2018
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Lisa B Orr, Sateesh Kum Sathigari
10 Aug 2018
21 CFR 211.42(c)(5)
Mfg / Processing Operations Area
Cited by Lisa B Orr, Sateesh Kum Sathigari
Investigators
FDA investigators tied to this site in the record.
Azza Talaat2 insp.
Felix Maldonado1 insp.
Lisa B Orr1 insp.
Sateesh Kum Sathigari1 insp.
Chad N Thompson1 insp.
David J Gomes1 insp.
Nicholas L Paulin1 insp.
Linda Thai1 insp.
Sandra A Hughes1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Haupt Pharma Wuelfing GmbH'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