Vitae Enim Vitae Scientific, Inc.
Form 483 issued September 22, 2021 · San Diego, California
- Inspection
- Sep 13 – Sep 22, 2021
- Investigator
- Saied A. Asbagh
- Observations
- 8
- Pages
- 6
- FEI number
- 3014384422
In short: On September 22, 2021, FDA issued a Form 483 with 8 observations to Vitae Enim Vitae Scientific, Inc. in San Diego, California (FEI 3014384422) after an inspection that ran Sep 13 – Sep 22, 2021. The investigator was Saied A. Asbagh. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Time limits are not established when appropriate for the completion of each production phase to assure…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Saied A. Asbagh
12 documents · 2016–2024
Cites 211.22 (responsibilities of quality control unit) 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 211.22(d)
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 8 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Vitae Enim Vitae Scientific, Inc.?
Saied A. Asbagh is named on this Form 483, for the inspection of Sep 13 – Sep 22, 2021. Each investigator has a profile showing what they cite most.
When was Vitae Enim Vitae Scientific, Inc. inspected by FDA?
The inspection ran Sep 13 – Sep 22, 2021, and the Form 483 is dated September 22, 2021.
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.