Burt's Pharmacy, LLC
Form 483 issued October 7, 2022 · ewbury Park, California
- Inspection
- Oct 4 – Oct 7, 2022
- Investigator
- Nicholas L. Hunt
- Observations
- 4
- Pages
- 4
- FEI number
- 3011924560
In short: On October 7, 2022, FDA issued a Form 483 with 4 observations to Burt's Pharmacy, LLC in ewbury Park, California (FEI 3011924560) after an inspection that ran Oct 4 – Oct 7, 2022. The investigator was Nicholas L. Hunt. Most observations concern facilities & equipment and 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
Facilities & equipment and materials account for 3 of 4 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
N on-pharmaceutical grade components are used in the formulation…
- 02
Hazardous and non-hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces…
- 03
Your firm released drug product in which the strength differs from, or its purity or quality…
- 04
Vermin was observed in…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmBurt's Pharmacy, LLC history
The site's inspection history, in date order.
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 Burt's Pharmacy, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. 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 Burt's Pharmacy, LLC?
Nicholas L. Hunt is named on this Form 483, for the inspection of Oct 4 – Oct 7, 2022. Each investigator has a profile showing what they cite most.
When was Burt's Pharmacy, LLC inspected by FDA?
The inspection ran Oct 4 – Oct 7, 2022, and the Form 483 is dated October 7, 2022.
How do I get the full Form 483 for Burt's 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.