Coronado Aesthetics LLC
Form 483 issued August 22, 2025 · Dallas, Texas
- Inspection
- Aug 19 – Aug 22, 2025
- Investigators
- Daniel J. Lahar· Yuliana Hernandez-Magana
- Observations
- 4
- Pages
- 5
- FEI number
- 3021159346
In short: On August 22, 2025, FDA issued a Form 483 with 4 observations to Coronado Aesthetics LLC in Dallas, Texas (FEI 3021159346) after an inspection that ran Aug 19 – Aug 22, 2025. The investigators were Daniel J. Lahar and Yuliana Hernandez-Magana. Most observations concern design controls and management controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and management controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design validation have…
- 02
Procedures for design review have not been…
- 03
Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at…
- 0421 CFR 820.2221 CFR 820
Quality audits have not…
This inspection in context
Daniel J. Lahar
3 documents · 2007–2025
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmCoronado Aesthetics LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Coronado Aesthetics LLC?
FDA listed 4 observations on this Form 483, mostly about design controls and management controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Coronado Aesthetics LLC?
Daniel J. Lahar and Yuliana Hernandez-Magana are named on this Form 483, for the inspection of Aug 19 – Aug 22, 2025. Each investigator has a profile showing what they cite most.
When was Coronado Aesthetics LLC inspected by FDA?
The inspection ran Aug 19 – Aug 22, 2025, and the Form 483 is dated August 22, 2025.
How do I get the full Form 483 for Coronado Aesthetics 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.