Company
GermanyHaupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany – FDA Inspections
Inspection records and compliance data for Haupt Pharma Wolfratshausen GmbH in Wolfratshausen. 6 FDA inspections on record, 1 Form 483, last inspected November 15, 2022.
Company Profile
This profile covers Haupt Pharma Wolfratshausen GmbH based in Wolfratshausen, Germany.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 6
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected May 11, 2012. Last inspected November 15, 2022.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Investigations of discrepancies, failures1 inspection
- Procedures for sterile drug products1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 15, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1190765 |
| August 5, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1133484 |
| October 20, 2017 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 1031639 |
| April 9, 2016 | VAI | Human Drugs · Drug Quality Assurance | 964643 |
| March 18, 2014 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 876712 |
| May 11, 2012 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 790703 |
FDA documents
Form 483s (1)
EIRs (1)
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Company Information
Name
Haupt Pharma Wolfratshausen GmbH
FEI Number
3000310230
Address
Pfaffenrieder Str. 5, Wolfratshausen, Germany
Country
Germany
ID: c95278bf-619e-48d6-965b-308ac8af4620