Elevate Oral Care
Form 483 issued September 6, 2019 · West Palm Beach, Florida
- Investigator
- Jennifer L. Huntington
- Observations
- 3
- Pages
- 3
- FEI number
- 3009603151
In short: On September 6, 2019, FDA issued a Form 483 with 3 observations to Elevate Oral Care in West Palm Beach, Florida (FEI 3009603151). The investigator was Jennifer L. Huntington. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Procedures describing the handling of all written and oral complaints regarding a drug…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
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 firmElevate Oral Care history
The site's inspection history, in date order.
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 Elevate Oral Care?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Elevate Oral Care?
Jennifer L. Huntington is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Elevate Oral Care inspected by FDA?
This Form 483 is dated September 6, 2019.
How do I get the full Form 483 for Elevate Oral Care?
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.