Lotte Biologics USA, LLC
Form 483 issued June 5, 2019 · East Syracuse, New York
- Inspection
- May 28 – Jun 5, 2019
- Observations
- 1
- Pages
- 3
- FEI number
- 1317757
In short: On June 5, 2019, FDA issued a Form 483 with 1 observation to Lotte Biologics USA, LLC in East Syracuse, New York (FEI 1317757) after an inspection that ran May 28 – Jun 5, 2019. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Questions about this 483
What did FDA find at Lotte Biologics USA, LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Lotte Biologics USA, LLC inspected by FDA?
The inspection ran May 28 – Jun 5, 2019, and the Form 483 is dated June 5, 2019.
How do I get the full Form 483 for Lotte Biologics 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.