United Laboratories Manufacturing, LLC
FDA inspection history in Carrollton, Texas, 2010 to 2025
- 4
- Form 483s
Every document, by year
- Form 483
2010: one Form 483; 2016: one Form 483; 2018: one Form 483; 2025: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One Form 483, at Carrollton, Texas.
- 2016–18Two Form 483s, at Carrollton, Texas.
- 2025One amended 483, at Carrollton, Texas.
- 2025The longest 483 on file: 8 observations over 10 pages at Carrollton, Texas.
Cited most
Across all United Laboratories Manufacturing observations on file
- 21 CFR 211.188Batch production and control records4
- 21 CFR 211.67(a)Equipment cleaning and maintenance3
- 21 CFR 111.75(a)(1)(i)What must you do to determine whether specifications are met?2
- 21 CFR 111.365(a)What precautions must you take to prevent contamination?1
- 21 CFR 111.553What are the requirements under this subpart O for written procedures?1
The complete United Laboratories Manufacturing file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Carrollton, Texas
Three Form 483s and one amended 483 · 2010 to 2025 · 26 observations
Latest: Form 483, Aug 15, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-08-15 | Amended 483 Amended 483 | Carrollton, Texas | 8 | $99 |
| 2018-04-09 | 483 Form 483 | Carrollton, Texas | 8 | $99 |
| 2016-08-26 | 483 Form 483 | Carrollton, Texas | 2 | $99 |
| 2010-08-12 | 483 Form 483 | Carrollton, Texas | 8 | $99 |
Investigators on these documents
Adrian Rodriguez (1)Mercedes N. Overton (1)Nimmy Mathews (1)Patrice S. Hall (1)Shelby N. Marler (1)Shelby N. Turner (1)Trina K. Vick (1)
FEI number 3006056935 · most recent document Aug 15, 2025
About United Laboratories Manufacturing, LLC
How many FDA Form 483s has United Laboratories Manufacturing, LLC received?
FDA Intel has 4 Form 483s on file for United Laboratories Manufacturing, LLC; the most recent is dated Aug 15, 2025.
When was United Laboratories Manufacturing, LLC last inspected by FDA?
The most recent FDA inspection document on file for United Laboratories Manufacturing, LLC is a Form 483 dated Aug 15, 2025, for the site in Carrollton, Texas.
What did FDA cite at United Laboratories Manufacturing, LLC?
The regulations cited most in the observations on file for United Laboratories Manufacturing, LLC are 21 CFR 211.188 (Batch production and control records), 4 times; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 3 times; 21 CFR 111.75(a)(1)(i) (What must you do to determine whether specifications are met?), 2 times.