Delasco, LLC
Form 483 issued January 14, 2025 · Plano, Texas
- Inspection
- Jan 13 – Jan 14, 2025
- Investigators
- Katherine M. Thames· Roy Baby
- Observations
- 4
- Pages
- 5
- FEI number
- 1930126
In short: On January 14, 2025, FDA issued a Form 483 with 4 observations to Delasco, LLC in Plano, Texas (FEI 1930126) after an inspection that ran Jan 13 – Jan 14, 2025. The investigators were Katherine M. Thames and Roy Baby. Most observations concern cAPA and production & process controls.
At a glance
3 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have not been…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 03
Procedures for corrective and preventive action…
- 04
Procedures for acceptance activities…
This inspection in context
Katherine M. Thames
6 documents · 2025–2026
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Texas.
The firmDelasco, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Delasco, LLC?
FDA listed 4 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Delasco, LLC?
Katherine M. Thames and Roy Baby are named on this Form 483, for the inspection of Jan 13 – Jan 14, 2025. Each investigator has a profile showing what they cite most.
When was Delasco, LLC inspected by FDA?
The inspection ran Jan 13 – Jan 14, 2025, and the Form 483 is dated January 14, 2025.
How do I get the full Form 483 for Delasco, 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.