Haupt Pharma Wolfratshausen GmbH
Form 483 issued May 11, 2012 · Wolfratshausen, Germany
- Inspection
- May 3 – May 11, 2012
- Investigator
- Margaret M. Annes
- Observations
- 5
- Pages
- 2
- FEI number
- 3000310230
In short: On May 11, 2012, FDA issued a Form 483 with 5 observations to Haupt Pharma Wolfratshausen GmbH in Wolfratshausen, Germany (FEI 3000310230) after an inspection that ran May 3 – May 11, 2012. The investigator was Margaret M. Annes. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and materials account for 4 of 5 observations.
Most cited: 21 CFR 211.42 (2×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment used to…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Written procedures for production and process controls designed to assure that the drug products have the…
- 04
Each lot of a closure that is liable to microbiological contamination that is objectionable in view…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmHaupt Pharma Wolfratshausen GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Haupt Pharma Wolfratshausen GmbH?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, materials and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Haupt Pharma Wolfratshausen GmbH?
Margaret M. Annes is named on this Form 483, for the inspection of May 3 – May 11, 2012. Each investigator has a profile showing what they cite most.
When was Haupt Pharma Wolfratshausen GmbH inspected by FDA?
The inspection ran May 3 – May 11, 2012, and the Form 483 is dated May 11, 2012.
How do I get the full Form 483 for Haupt Pharma Wolfratshausen GmbH?
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