La Vita Compounding Pharmacy, LLC
Form 483 issued March 11, 2020 · San Diego, California
- Inspection
- Mar 4 – Mar 11, 2020
- Investigators
- Nathaniel B. Phillips-Sylvain· Zachary A. Bogorad
- Observations
- 4
- Pages
- 4
- FEI number
- 3009571102
In short: On March 11, 2020, FDA issued a Form 483 with 4 observations to La Vita Compounding Pharmacy, LLC in San Diego, California (FEI 3009571102) after an inspection that ran Mar 4 – Mar 11, 2020. The investigators were Nathaniel B. Phillips-Sylvain and Zachary A. Bogorad. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 1 system, led by materials.
Most cited: FDCA 501(a)(2)(A) (3×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You used a non-pharmaceutical grade component in the formulation…
- 02FDCA 501(a)(2)(A)
Personnel donned gowning apparel improperly, in a way that may have caused the gowning…
- 03FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had paiticle-generating and visibly…
- 04FDCA 501(a)(2)(A)
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
This inspection in context
Nathaniel B. Phillips-Sylvain
6 documents · 2020–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Washington.
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 211.84
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 4 observations on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected La Vita Compounding Pharmacy, LLC?
Nathaniel B. Phillips-Sylvain and Zachary A. Bogorad are named on this Form 483, for the inspection of Mar 4 – Mar 11, 2020. Each investigator has a profile showing what they cite most.
When was La Vita Compounding Pharmacy, LLC inspected by FDA?
The inspection ran Mar 4 – Mar 11, 2020, and the Form 483 is dated March 11, 2020.
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.