Kaysersberg Pharmaceuticals
Form 483 issued July 19, 2016
- Inspection
- Jul 11 – Jul 19, 2016
- Investigator
- Xmichael A. Charles
- Observations
- 8
- Pages
- 4
- FEI number
- 3002806288
In short: On July 19, 2016, FDA issued a Form 483 with 8 observations to Kaysersberg Pharmaceuticals (FEI 3002806288) after an inspection that ran Jul 11 – Jul 19, 2016. The investigator was Xmichael A. Charles. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
There is a lack of written procedures describing in sufficient detail the methods, equipment and materials…
- 04
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
This inspection in context
Xmichael A. Charles
1 document · 2016
Cites 211.100(b) (written procedures; deviations) more than any other section.
The firmKaysersberg Pharmaceuticals history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kaysersberg Pharmaceuticals?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Kaysersberg Pharmaceuticals?
Xmichael A. Charles is named on this Form 483, for the inspection of Jul 11 – Jul 19, 2016. Each investigator has a profile showing what they cite most.
When was Kaysersberg Pharmaceuticals inspected by FDA?
The inspection ran Jul 11 – Jul 19, 2016, and the Form 483 is dated July 19, 2016.
How do I get the full Form 483 for Kaysersberg Pharmaceuticals?
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.