Haupt Pharma Muenster GmbH
Form 483 issued July 6, 2018 · Muenster, Germany
- Inspection
- Jul 2 – Jul 6, 2018
- Investigator
- Doan T. Nguyen
- Observations
- 3
- Pages
- 4
- FEI number
- 3006010798
In short: On July 6, 2018, FDA issued a Form 483 with 3 observations to Haupt Pharma Muenster GmbH in Muenster, Germany (FEI 3006010798) after an inspection that ran Jul 2 – Jul 6, 2018. The investigator was Doan T. Nguyen. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Doan T. Nguyen
8 documents · 2014–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Germany.
The firmHaupt Pharma Muenster GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Haupt Pharma Muenster GmbH?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Haupt Pharma Muenster GmbH?
Doan T. Nguyen is named on this Form 483, for the inspection of Jul 2 – Jul 6, 2018. Each investigator has a profile showing what they cite most.
When was Haupt Pharma Muenster GmbH inspected by FDA?
The inspection ran Jul 2 – Jul 6, 2018, and the Form 483 is dated July 6, 2018.
How do I get the full Form 483 for Haupt Pharma Muenster GmbH?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.