PharmaZell GmbH
Form 483 issued September 22, 2017 · Raubling, Germany
- Inspection
- Sep 18 – Sep 22, 2017
- Investigator
- Deyaa Shaheen
- Observations
- 3
- Pages
- 3
- FEI number
- 3003725792
In short: On September 22, 2017, FDA issued a Form 483 with 3 observations to PharmaZell GmbH in Raubling, Bavaria (FEI 3003725792) after an inspection that ran Sep 18 – Sep 22, 2017. The investigator was Deyaa Shaheen. Most observations concern laboratory controls and quality system.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Quality System) The responsibilities and procedures applicable to the quality control unit are not in…
- 02
(Laboratory System) Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures…
- 03
An adequate number of batches of each drug product are not tested nor are records of…
This inspection in context
Deyaa Shaheen
5 documents · 2016–2017
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Germany.
The firmPharmaZell GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharmaZell GmbH?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected PharmaZell GmbH?
Deyaa Shaheen is named on this Form 483, for the inspection of Sep 18 – Sep 22, 2017. Each investigator has a profile showing what they cite most.
When was PharmaZell GmbH inspected by FDA?
The inspection ran Sep 18 – Sep 22, 2017, and the Form 483 is dated September 22, 2017.
How do I get the full Form 483 for PharmaZell 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.