Siegfried USA, LLC
Form 483 issued September 27, 2023 · Pennsville, New Jersey
- Inspection
- Sep 18 – Sep 27, 2023
- Observations
- 1
- Pages
- 3
- FEI number
- 2227314
In short: On September 27, 2023, FDA issued a Form 483 with 1 observation to Siegfried USA, LLC in Pennsville, New Jersey (FEI 2227314) after an inspection that ran Sep 18 – Sep 27, 2023. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Suitability and verification of test methods failed to use reference standards that were stored under acceptable…
This inspection in context
Questions about this 483
What did FDA find at Siegfried USA, LLC?
FDA listed 1 observation 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.
When was Siegfried USA, LLC inspected by FDA?
The inspection ran Sep 18 – Sep 27, 2023, and the Form 483 is dated September 27, 2023.
How do I get the full Form 483 for Siegfried USA, LLC?
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.