Loba Feinchemie GmbH
Form 483 issued November 11, 2025 · Fischamend, Austria
- Inspection
- Nov 3 – Nov 11, 2025
- Investigator
- Neha Gupta
- Observations
- 7
- Pages
- 5
- FEI number
- 3002807485
In short: On November 11, 2025, FDA issued a Form 483 with 7 observations to Loba Feinchemie GmbH in Fischamend, Austria (FEI 3002807485) after an inspection that ran Nov 3 – Nov 11, 2025. The investigator was Neha Gupta. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 6 of 7 observations.
Most cited: 21 CFR 211.192 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Master Batch Record for®@ does not…
- 02
You failed to take adequate corrective action preventative action (CAPA) for a manufacturing system, resolution of…
- 03
Validations in support of »@ drug…
- 04
Equipment, facilities and a utility system in support of m@ drug substance manufacture are not adequately…
This inspection in context
Neha Gupta
1 document · 2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Austria.
The firmLoba Feinchemie GmbH history
The site's inspection history, in date order.
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 Loba Feinchemie GmbH?
FDA listed 7 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Loba Feinchemie GmbH?
Neha Gupta is named on this Form 483, for the inspection of Nov 3 – Nov 11, 2025. Each investigator has a profile showing what they cite most.
When was Loba Feinchemie GmbH inspected by FDA?
The inspection ran Nov 3 – Nov 11, 2025, and the Form 483 is dated November 11, 2025.
How do I get the full Form 483 for Loba Feinchemie 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.