Livent USA Corp.
Form 483 issued February 7, 2020 · Bessemer City, North Carolina
- Inspection
- Feb 3 – Feb 7, 2020
- Investigator
- Jaye Edwards
- Observations
- 3
- Pages
- 3
- FEI number
- 1015213
In short: On February 7, 2020, FDA issued a Form 483 with 3 observations to Livent USA Corp. in Bessemer City, North Carolina (FEI 1015213) after an inspection that ran Feb 3 – Feb 7, 2020. The investigator was Jaye Edwards. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Written procedure for Out of Specification Laboratory…
- 03
Complaint procedure is…
This inspection in context
Jaye Edwards
1 document · 2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in North Carolina.
The firmLivent USA Corp. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Livent USA Corp.?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Livent USA Corp.?
Jaye Edwards is named on this Form 483, for the inspection of Feb 3 – Feb 7, 2020. Each investigator has a profile showing what they cite most.
When was Livent USA Corp. inspected by FDA?
The inspection ran Feb 3 – Feb 7, 2020, and the Form 483 is dated February 7, 2020.
How do I get the full Form 483 for Livent USA Corp.?
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.