La Vita Compounding Pharmacy, LLC
Form 483 issued June 4, 2018 · San Diego, California
- Inspection
- Jun 4, 2018
- Investigator
- Roger F. Zabinski
- Observations
- 5
- Pages
- 4
- FEI number
- 3009571102
In short: On June 4, 2018, FDA issued a Form 483 with 5 observations to La Vita Compounding Pharmacy, LLC in San Diego, California (FEI 3009571102) after an inspection that ran Jun 4, 2018. The investigator was Roger F. Zabinski. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm produced drugs while construction was underway in an adjacent area without adequate controls to…
- 02
Unsealed, loose ceiling tiles were…
- 03
The segregated production areas surrounding the ISO 5 classified aseptic processing area contained dust-collecting overhangs without…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmLa Vita Compounding Pharmacy, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at La Vita Compounding Pharmacy, LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected La Vita Compounding Pharmacy, LLC?
Roger F. Zabinski is named on this Form 483, for the inspection of Jun 4, 2018. Each investigator has a profile showing what they cite most.
When was La Vita Compounding Pharmacy, LLC inspected by FDA?
The inspection ran Jun 4, 2018, and the Form 483 is dated June 4, 2018.
How do I get the full Form 483 for La Vita Compounding Pharmacy, 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.