Allure Labs, LLC
Form 483 issued November 23, 2020 · Hayward, California
- Inspection
- Nov 16 – Nov 23, 2020
- Investigator
- Jeffrey P. Raimondi
- Observations
- 7
- Pages
- 7
- FEI number
- 3000204079
In short: On November 23, 2020, FDA issued a Form 483 with 7 observations to Allure Labs, LLC in Hayward, California (FEI 3000204079) after an inspection that ran Nov 16 – Nov 23, 2020. The investigator was Jeffrey P. Raimondi. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) 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 211.67(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 laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Allure Labs, LLC?
Jeffrey P. Raimondi is named on this Form 483, for the inspection of Nov 16 – Nov 23, 2020. Each investigator has a profile showing what they cite most.
When was Allure Labs, LLC inspected by FDA?
The inspection ran Nov 16 – Nov 23, 2020, and the Form 483 is dated November 23, 2020.
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.