Allure Labs, LLC
Form 483 issued October 25, 2017 · Hayward, California
- Inspection
- Oct 16 – Oct 25, 2017
- Investigator
- Kristin M. Abaonza
- Observations
- 7
- Pages
- 11
- FEI number
- 3000204079
In short: On October 25, 2017, FDA issued a Form 483 with 7 observations to Allure Labs, LLC in Hayward, California (FEI 3000204079) after an inspection that ran Oct 16 – Oct 25, 2017. The investigator was Kristin M. Abaonza. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.170 (reserve samples).
At a glance
Observations span 4 systems, led by materials.
Most cited: 21 CFR 211.170(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the warehousing of drug products are not followed. A) Your firm failed to follow…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Written procedures are not followed for the receipt, identification, storage, handling, approval…
- 04
Reserve drug product samples are not retained and stored under conditions consistent with product labeling. A)…
This inspection in context
Kristin M. Abaonza
12 documents · 2015–2026
Cites 211.160 (general requirements) 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 211.170(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allure Labs, LLC?
FDA listed 7 observations on this Form 483, mostly about materials, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.170 (reserve samples). The opening words of each observation are shown on this page.
Who inspected Allure Labs, LLC?
Kristin M. Abaonza is named on this Form 483, for the inspection of Oct 16 – Oct 25, 2017. Each investigator has a profile showing what they cite most.
When was Allure Labs, LLC inspected by FDA?
The inspection ran Oct 16 – Oct 25, 2017, and the Form 483 is dated October 25, 2017.
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.