United Laboratories Manufacturing, LLC
Amended 483 issued August 15, 2025 · Carrollton, Texas
- Inspection
- Aug 4 – Aug 15, 2025
- Investigators
- Mercedes N. Overton· Shelby N. Turner
- Observations
- 8
- Pages
- 10
- FEI number
- 3006056935
In short: On August 15, 2025, FDA issued a Amended 483 with 8 observations to United Laboratories Manufacturing, LLC in Carrollton, Texas (FEI 3006056935) after an inspection that ran Aug 4 – Aug 15, 2025. The investigators were Mercedes N. Overton and Shelby N. Turner. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Drug products failing to meet established standards, specifications and quality control…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Employees are not given training in…
4 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Mercedes N. Overton
2 documents · 2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Texas.
The firmUnited Laboratories Manufacturing, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at United Laboratories Manufacturing, LLC?
FDA listed 8 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected United Laboratories Manufacturing, LLC?
Mercedes N. Overton and Shelby N. Turner are named on this Amended 483, for the inspection of Aug 4 – Aug 15, 2025. Each investigator has a profile showing what they cite most.
When was United Laboratories Manufacturing, LLC inspected by FDA?
The inspection ran Aug 4 – Aug 15, 2025, and the Amended 483 is dated August 15, 2025.
How do I get the full Amended 483 for United Laboratories Manufacturing, 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.