Zile Bonbons AG
Form 483 issued July 12, 2023 · Rupperswil, Switzerland
- Inspection
- Jul 6 – Jul 12, 2023
- Investigator
- Arsen Karapetyan
- Observations
- 9
- Pages
- 8
- FEI number
- 3003236010
In short: On July 12, 2023, FDA issued a Form 483 with 9 observations to Zile Bonbons AG in Rupperswil, Aargau (FEI 3003236010) after an inspection that ran Jul 6 – Jul 12, 2023. The investigator was Arsen Karapetyan. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.100(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 04
Your firm failed to establish adequate written procedures for production…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmZile Bonbons AG history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zile Bonbons AG?
FDA listed 9 observations on this Form 483, mostly about production, facilities & equipment and packaging & labeling. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Zile Bonbons AG?
Arsen Karapetyan is named on this Form 483, for the inspection of Jul 6 – Jul 12, 2023. Each investigator has a profile showing what they cite most.
When was Zile Bonbons AG inspected by FDA?
The inspection ran Jul 6 – Jul 12, 2023, and the Form 483 is dated July 12, 2023.
How do I get the full Form 483 for Zile Bonbons AG?
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