Chemische Fabrik Berg GmbH
Form 483 issued June 29, 2018 · Bitterfeld-Wolfen, Germany
- Inspection
- Jun 25 – Jun 29, 2018
- Investigator
- Doan T. Nguyen
- Observations
- 7
- Pages
- 6
- FEI number
- 3003004618
In short: On June 29, 2018, FDA issued a Form 483 with 7 observations to Chemische Fabrik Berg GmbH in Bitterfeld-Wolfen, Germany (FEI 3003004618) after an inspection that ran Jun 25 – Jun 29, 2018. The investigator was Doan T. Nguyen. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 6 of 7 observations.
Most cited: 21 CFR 211.68 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over…
- 02
Appropriate controls are not exercised over computers or related systems to assure changes in master production…
- 03
Appropriate controls are not exercised over computers or related systems to assure changes in master production…
- 04
Repeat observation Failure to have adequate written procedures or failure to…
This inspection in context
Doan T. Nguyen
8 documents · 2014–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Germany.
The firmChemische Fabrik Berg 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 Chemische Fabrik Berg GmbH?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Chemische Fabrik Berg GmbH?
Doan T. Nguyen is named on this Form 483, for the inspection of Jun 25 – Jun 29, 2018. Each investigator has a profile showing what they cite most.
When was Chemische Fabrik Berg GmbH inspected by FDA?
The inspection ran Jun 25 – Jun 29, 2018, and the Form 483 is dated June 29, 2018.
How do I get the full Form 483 for Chemische Fabrik Berg GmbH?
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