Encore Laboratory
Form 483 issued January 9, 2026
- Inspection
- Jan 7 – Jan 9, 2026
- Investigator
- Alexandria L. Capuano
- Observations
- 5
- Pages
- 6
- FEI number
- 3020749939
In short: On January 9, 2026, FDA issued a Form 483 with 5 observations to Encore Laboratory (FEI 3020749939) after an inspection that ran Jan 7 – Jan 9, 2026. The investigator was Alexandria L. Capuano. Most observations concern cAPA and records & documents.
At a glance
CAPA and records & documents account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 82021 CFR 820.184
The device history record does not demonstrate that the device was manufactured in accordance with the…
- 02
Products that do not conform to specifications…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 0421 CFR 830
The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet…
This inspection in context
Alexandria L. Capuano
6 documents · 2022–2026
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in California.
The firmEncore Laboratory history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Encore Laboratory?
FDA listed 5 observations on this Form 483, mostly about cAPA, records & documents and management controls. The opening words of each observation are shown on this page.
Who inspected Encore Laboratory?
Alexandria L. Capuano is named on this Form 483, for the inspection of Jan 7 – Jan 9, 2026. Each investigator has a profile showing what they cite most.
When was Encore Laboratory inspected by FDA?
The inspection ran Jan 7 – Jan 9, 2026, and the Form 483 is dated January 9, 2026.
How do I get the full Form 483 for Encore Laboratory?
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.