Allure Labs, LLC
Form 483 issued March 27, 2026 · Hayward, California
- Inspection
- Mar 23 – Mar 27, 2026
- Investigator
- Nathan E. Hellman
- Observations
- 3
- Pages
- 4
- FEI number
- 3000204079
In short: On March 27, 2026, FDA issued a Form 483 with 3 observations to Allure Labs, LLC in Hayward, California (FEI 3000204079) after an inspection that ran Mar 23 – Mar 27, 2026. The investigator was Nathan E. Hellman. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
The accuracy of test methods…
This inspection in context
Nathan E. Hellman
6 documents · 2025–2026
Cites 211.84(a) (testing and approval or rejection of components, drug product containers, and closures) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allure Labs, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Allure Labs, LLC?
Nathan E. Hellman is named on this Form 483, for the inspection of Mar 23 – Mar 27, 2026. Each investigator has a profile showing what they cite most.
When was Allure Labs, LLC inspected by FDA?
The inspection ran Mar 23 – Mar 27, 2026, and the Form 483 is dated March 27, 2026.
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.