Noble Panacea Labs, Inc
Form 483 issued November 8, 2024 · Irvine, California
- Inspection
- Nov 4 – Nov 8, 2024
- Investigators
- Rachel C. Stanton· Rowena S. Nguyen
- Observations
- 11
- Pages
- 11
- FEI number
- 3027485555
In short: On November 8, 2024, FDA issued a Form 483 with 11 observations to Noble Panacea Labs, Inc in Irvine, California (FEI 3027485555) after an inspection that ran Nov 4 – Nov 8, 2024. The investigators were Rachel C. Stanton and Rowena S. Nguyen. 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 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
The plumbing system contains defects that could contribute to the…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Rachel C. Stanton
5 documents · 2022–2024
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmNoble Panacea Labs, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Noble Panacea Labs, Inc?
FDA listed 11 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Noble Panacea Labs, Inc?
Rachel C. Stanton and Rowena S. Nguyen are named on this Form 483, for the inspection of Nov 4 – Nov 8, 2024. Each investigator has a profile showing what they cite most.
When was Noble Panacea Labs, Inc inspected by FDA?
The inspection ran Nov 4 – Nov 8, 2024, and the Form 483 is dated November 8, 2024.
How do I get the full Form 483 for Noble Panacea Labs, 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.