Business for Advanced Innovation, LLC
Form 483 issued August 29, 2018 · Lake Worth, Florida
- Inspection
- Aug 27 – Aug 29, 2018
- Investigator
- Jennifer L. Huntington
- Observations
- 1
- Pages
- 4
- FEI number
- 3010165762
In short: On August 29, 2018, FDA issued a Form 483 with 1 observation to Business for Advanced Innovation, LLC in Lake Worth, Florida (FEI 3010165762) after an inspection that ran Aug 27 – Aug 29, 2018. The investigator was Jennifer L. Huntington. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmBusiness for Advanced Innovation, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Business for Advanced Innovation, LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Business for Advanced Innovation, LLC?
Jennifer L. Huntington is named on this Form 483, for the inspection of Aug 27 – Aug 29, 2018. Each investigator has a profile showing what they cite most.
When was Business for Advanced Innovation, LLC inspected by FDA?
The inspection ran Aug 27 – Aug 29, 2018, and the Form 483 is dated August 29, 2018.
How do I get the full Form 483 for Business for Advanced Innovation, 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.