Buchler GmbH
Form 483 issued August 15, 2019 · Braunschweig, Germany
- Investigator
- Ever Se
- Observations
- 3
- Pages
- 1
- FEI number
- 3002806608
In short: On August 15, 2019, FDA issued a Form 483 with 3 observations to Buchler GmbH in Braunschweig, Germany (FEI 3002806608). The investigator was Ever Se. Most observations concern facilities & equipment and laboratory controls.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Computer systems were not properly validated to ensure all raw data, including data changes from previous…
- 02
The cleaning validation protocol should describe the equipment to be cleaned, pracedures, materials, acceptable cleaning levels…
- 03
Stability samples should include all containers…
This inspection in context
Ever Se
1 document · 2019
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Germany.
The firmBuchler GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Buchler GmbH?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Buchler GmbH?
Ever Se is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Buchler GmbH inspected by FDA?
This Form 483 is dated August 15, 2019.
How do I get the full Form 483 for Buchler 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.