Vitae Enim Vitae Scientific, Inc.
Form 483 issued January 7, 2025 · San Diego, California
- Inspection
- Jan 7, 2025
- Investigator
- Joey V. Quitania
- Observations
- 7
- Pages
- 6
- FEI number
- 3014384422
In short: On January 7, 2025, FDA issued a Form 483 with 7 observations to Vitae Enim Vitae Scientific, Inc. in San Diego, California (FEI 3014384422) after an inspection that ran Jan 7, 2025. The investigator was Joey V. Quitania. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmVitae Enim Vitae Scientific, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vitae Enim Vitae Scientific, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Vitae Enim Vitae Scientific, Inc.?
Joey V. Quitania is named on this Form 483, for the inspection of Jan 7, 2025. Each investigator has a profile showing what they cite most.
When was Vitae Enim Vitae Scientific, Inc. inspected by FDA?
The inspection ran Jan 7, 2025, and the Form 483 is dated January 7, 2025.
How do I get the full Form 483 for Vitae Enim Vitae Scientific, Inc.?
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.