Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-15.
At a glance
Inspections
10
Form 483s
6
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Nov 2022 – 15 Nov 2022 | Human Drugs | 483 | View 483 → |
| 1 Feb 2021 – 8 Feb 2021 | Human Drugs | Clean | |
| 3 Aug 2020 – 5 Aug 2020 | Human Drugs | Clean | |
| 10 Feb 2020 – 14 Feb 2020 | Human Drugs | Clean | |
| 12 Oct 2017 – 20 Oct 2017 | Human Drugs | 483 | On file |
| 4 Apr 2016 – 9 Apr 2016 | Human Drugs | 483 | View 483 → |
| 10 Mar 2014 – 18 Mar 2014 | Human Drugs | 483 | View 483 → |
| 11 May 2012 | Not recorded | 483 | On file |
| 15 Apr 2008 | Not recorded | 483 | On file |
| 23 Nov 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Nov 2022
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Guerlain Ulysse, Xiaokuang Lai
15 Nov 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Guerlain Ulysse, Xiaokuang Lai
15 Nov 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Guerlain Ulysse, Xiaokuang Lai
9 Apr 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Meisha R Sampson, David D Anderson, Meisha R Waters
9 Apr 2016
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Meisha R Sampson, David D Anderson, Meisha R Waters
Investigators
FDA investigators tied to this site in the record.
MRA DavisM2 insp.
Guerlain Ulysse1 insp.
Xiaokuang Lai1 insp.
Nayan J Patel1 insp.
Sangeeta M Khurana1 insp.
Meisha R Sampson1 insp.
David D Anderson1 insp.
Meisha R Waters1 insp.
Lance M De Souza1 insp.
Margaret M Annes1 insp.
Jeremy W Rotton1 insp.
Paul A Bonneau1 insp.
Susan P Bruederle1 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 | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Haupt Pharma Wolfratshausen GmbH's 6 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