Northwest Cosmetic Laboratories L.L.C. DBA Elevation Labs
Form 483 issued February 24, 2020 · Idaho Falls, Idaho
- Inspection
- Feb 19 – Feb 24, 2020
- Investigator
- Scott N. Lim
- Observations
- 2
- Pages
- 4
- FEI number
- 1000524645
In short: On February 24, 2020, FDA issued a Form 483 with 2 observations to Northwest Cosmetic Laboratories L.L.C. DBA Elevation Labs in Idaho Falls, Idaho (FEI 1000524645) after an inspection that ran Feb 19 – Feb 24, 2020. The investigator was Scott N. Lim. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.110(a) (1×) · 211.165(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Scott N. Lim
14 documents · 2019–2026
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in California.
The firmNorthwest Cosmetic Laboratories L.L.C. DBA Elevation Labs history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Northwest Cosmetic Laboratories L.L.C. DBA Elevation Labs?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Northwest Cosmetic Laboratories L.L.C. DBA Elevation Labs?
Scott N. Lim is named on this Form 483, for the inspection of Feb 19 – Feb 24, 2020. Each investigator has a profile showing what they cite most.
When was Northwest Cosmetic Laboratories L.L.C. DBA Elevation Labs inspected by FDA?
The inspection ran Feb 19 – Feb 24, 2020, and the Form 483 is dated February 24, 2020.
How do I get the full Form 483 for Northwest Cosmetic Laboratories L.L.C. DBA Elevation Labs?
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.