K+S Minerals and Agriculture GmbH
Form 483 issued June 14, 2018 · Philippsthal, Germany
- Inspection
- Jun 11 – Jun 14, 2018
- Investigator
- Jamina S. Khan
- Observations
- 2
- Pages
- 1
- FEI number
- 3004269288
In short: On June 14, 2018, FDA issued a Form 483 with 2 observations to K+S Minerals and Agriculture GmbH in Philippsthal, Hessen (FEI 3004269288) after an inspection that ran Jun 11 – Jun 14, 2018. The investigator was Jamina S. Khan. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 211.170 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of appropriate specifications designed to assure that active pharmaceutical…
- 02
Reserve samples from representative batches of active pharmaceutical ingredient selected by acceptable statistical procedures are not…
This inspection in context
Jamina S. Khan
1 document · 2018
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Germany.
The firmK+S Minerals and Agriculture GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at K+S Minerals and Agriculture GmbH?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected K+S Minerals and Agriculture GmbH?
Jamina S. Khan is named on this Form 483, for the inspection of Jun 11 – Jun 14, 2018. Each investigator has a profile showing what they cite most.
When was K+S Minerals and Agriculture GmbH inspected by FDA?
The inspection ran Jun 11 – Jun 14, 2018, and the Form 483 is dated June 14, 2018.
How do I get the full Form 483 for K+S Minerals and Agriculture 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.