Mobren Transport Inc.
Form 483 issued November 18, 2021 · Sioux City, Iowa
- Observations
- 2
- Pages
- 3
- FEI number
- 3003232939
In short: On November 18, 2021, FDA issued a Form 483 with 2 observations to Mobren Transport Inc. in Sioux City, Iowa (FEI 3003232939). Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
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
Appropriate specifications have not been be established or met for crude heparin nano-concentrate in accordance ‘with…
- 02
Your firms investigation into a customer complaint of foreign material found in crude heprin nano-concentrate is…
This inspection in context
Questions about this 483
What did FDA find at Mobren Transport Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Mobren Transport Inc. inspected by FDA?
This Form 483 is dated November 18, 2021.
How do I get the full Form 483 for Mobren Transport Inc.?
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.