Genuine Virgin Aloe Corporation
Form 483 issued January 29, 2024 · Anaheim, California
- Inspection
- Jan 17 – Jan 29, 2024
- Investigator
- Carolina D. Vasquez
- Observations
- 8
- Pages
- 6
- FEI number
- 3008235829
In short: On January 29, 2024, FDA issued a Form 483 with 8 observations to Genuine Virgin Aloe Corporation in Anaheim, California (FEI 3008235829) after an inspection that ran Jan 17 – Jan 29, 2024. The investigator was Carolina D. Vasquez. Most observations concern quality system and production.
At a glance
Quality system and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
This inspection in context
Carolina D. Vasquez
9 documents · 2022–2026
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in California.
The firmGenuine Virgin Aloe Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genuine Virgin Aloe Corporation?
FDA listed 8 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Genuine Virgin Aloe Corporation?
Carolina D. Vasquez is named on this Form 483, for the inspection of Jan 17 – Jan 29, 2024. Each investigator has a profile showing what they cite most.
When was Genuine Virgin Aloe Corporation inspected by FDA?
The inspection ran Jan 17 – Jan 29, 2024, and the Form 483 is dated January 29, 2024.
How do I get the full Form 483 for Genuine Virgin Aloe Corporation?
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.