Novo Nordisk Pharmaceutical Industries LP
Form 483 issued July 13, 2023 · Clayton, North Carolina
- Inspection
- Jul 6 – Jul 13, 2023
- Investigators
- Brittny C. Cargo· Seneca Toms
- Observations
- 2
- Pages
- 3
- FEI number
- 1000158576
In short: On July 13, 2023, FDA issued a Form 483 with 2 observations to Novo Nordisk Pharmaceutical Industries LP in Clayton, North Carolina (FEI 1000158576) after an inspection that ran Jul 6 – Jul 13, 2023. The investigators were Brittny C. Cargo and Seneca Toms. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.113 (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 investigate the cause…
- 02
Microbial controls are deficient…
This inspection in context
Brittny C. Cargo
14 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Louisiana.
The firmNovo Nordisk Pharmaceutical Industries LP history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Novo Nordisk Pharmaceutical Industries LP?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Novo Nordisk Pharmaceutical Industries LP?
Brittny C. Cargo and Seneca Toms are named on this Form 483, for the inspection of Jul 6 – Jul 13, 2023. Each investigator has a profile showing what they cite most.
When was Novo Nordisk Pharmaceutical Industries LP inspected by FDA?
The inspection ran Jul 6 – Jul 13, 2023, and the Form 483 is dated July 13, 2023.
How do I get the full Form 483 for Novo Nordisk Pharmaceutical Industries LP?
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.