Allure Labs, Inc. – FDA Inspection, Oct 25, 2017

Record Details

This FDA Inspection record concerns Allure Labs, Inc., with an inspection on October 25, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Allure Labs, Inc.
Inspection Date: October 25, 2017
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Kristin M. Abaonza (FDA Associated Person)

View Company Profile

ID · fd45e9f8-488f-4dc9-9963-0b974aede050

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1030713
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.142Written warehousing procedures established/followed
21 CFR 211.170(b)Reserve samples identified, representative, stored
21 CFR 211.170(b)Annual visual exams of drug products
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.180(e)(1)Review of representative number of batches
21 CFR 211.80(a)Written Procedures Not Followed
21 CFR 211.100(b)SOPs not followed / documented

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Allure Labs, Inc.

Date	Classification	Office	Project area
March 27, 2026	Not classified	San Francisco District Office	Drug Quality Assurance
April 18, 2025	VAI	Center for Food Safety and Applied Nutrition	Colors and Cosmetics Technology
December 3, 2021	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
November 23, 2020	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance
August 21, 2015	VAI	Center for Food Safety and Applied Nutrition	Colors and Cosmetics Technology