Novo Nordisk Pharmaceutical Industries LP
Form 483 issued May 13, 2022 · Clayton, North Carolina
- Inspection
- May 9 – May 13, 2022
- Investigator
- Santos E. Camara
- Observations
- 3
- Pages
- 4
- FEI number
- 1000158576
In short: On May 13, 2022, FDA issued a Form 483 with 3 observations to Novo Nordisk Pharmaceutical Industries LP in Clayton, North Carolina (FEI 1000158576) after an inspection that ran May 9 – May 13, 2022. The investigator was Santos E. Camara. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 2 of 3 observations.
Most cited: 21 CFR 211.113 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to identify B. cepacia as an…
- 02
Failure to clean equipment at appropriate intervals to prevent build-up and carryover of contaminates degradants, microorganisms…
- 03
Failure to establish written procedures for use of suitable components to prevent contamination of equipment, raw…
This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.113
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 3 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Novo Nordisk Pharmaceutical Industries LP?
Santos E. Camara is named on this Form 483, for the inspection of May 9 – May 13, 2022. Each investigator has a profile showing what they cite most.
When was Novo Nordisk Pharmaceutical Industries LP inspected by FDA?
The inspection ran May 9 – May 13, 2022, and the Form 483 is dated May 13, 2022.
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.