Zile Bonbons AG

Form 483 issued August 31, 2017 · Rupperswil, Switzerland

Observations
1
Pages
4
FEI number
3003236010

In short: On August 31, 2017, FDA issued a Form 483 with 1 observation to Zile Bonbons AG in Rupperswil, Aargau (FEI 3003236010). The investigator was Charles B. Steinmiller. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.140 (under this subpart F, what records must you make and keep?).

At a glance

1 of 1 observations on this 483 concern dietary supplement cgmp.

Dietary supplement CGMP1

Most cited: 21 CFR 111.140(b)(1) (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 111.140(b)(1)

    You did not make and keep written procedures for the responsibilities of…

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This inspection in context

Questions about this 483

What did FDA find at Zile Bonbons AG?

FDA listed 1 observation on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.140 (under this subpart F, what records must you make and keep?). The opening words of each observation are shown on this page.

Who inspected Zile Bonbons AG?

Charles B. Steinmiller is named on this Form 483. Each investigator has a profile showing what they cite most.

When was Zile Bonbons AG inspected by FDA?

This Form 483 is dated August 31, 2017.

How do I get the full Form 483 for Zile Bonbons AG?

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