Allure Labs, LLC
Form 483 issued December 3, 2021 · Hayward, California
- Inspection
- Nov 29 – Dec 3, 2021
- Investigator
- Scott N. Lim
- Observations
- 4
- Pages
- 3
- FEI number
- 3000204079
In short: On December 3, 2021, FDA issued a Form 483 with 4 observations to Allure Labs, LLC in Hayward, California (FEI 3000204079) after an inspection that ran Nov 29 – Dec 3, 2021. The investigator was Scott N. Lim. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
Input to and output from the computer and records or data are…
- 04
There is a lack of written procedures assigning responsibility, providing cleaning schedules and describing in sufficient…
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 firmAllure Labs, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allure Labs, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Allure Labs, LLC?
Scott N. Lim is named on this Form 483, for the inspection of Nov 29 – Dec 3, 2021. Each investigator has a profile showing what they cite most.
When was Allure Labs, LLC inspected by FDA?
The inspection ran Nov 29 – Dec 3, 2021, and the Form 483 is dated December 3, 2021.
How do I get the full Form 483 for Allure Labs, LLC?
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.