United Laboratories Manufacturing, LLC
Form 483 issued August 12, 2010 · Carrollton, Texas
- Inspection
- Aug 11 – Aug 12, 2010
- Investigators
- Adrian Rodriguez· Trina K. Vick
- Observations
- 8
- Pages
- 6
- FEI number
- 3006056935
In short: On August 12, 2010, FDA issued a Form 483 with 8 observations to United Laboratories Manufacturing, LLC in Carrollton, Texas (FEI 3006056935) after an inspection that ran Aug 11 – Aug 12, 2010. The investigators were Adrian Rodriguez and Trina K. Vick. Most observations concern dietary supplement CGMP and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Dietary supplement CGMP and facilities & equipment account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
The written stability testing…
- 03
Written procedures for cleaning and maintenance fail to include parameters…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
This inspection in context
Adrian Rodriguez
1 document · 2010
Cites 111.75(a)(1)(i) (what must you do to determine whether specifications are met?) 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 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at United Laboratories Manufacturing, LLC?
FDA listed 8 observations on this Form 483, mostly about dietary supplement CGMP, facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected United Laboratories Manufacturing, LLC?
Adrian Rodriguez and Trina K. Vick are named on this Form 483, for the inspection of Aug 11 – Aug 12, 2010. Each investigator has a profile showing what they cite most.
When was United Laboratories Manufacturing, LLC inspected by FDA?
The inspection ran Aug 11 – Aug 12, 2010, and the Form 483 is dated August 12, 2010.
How do I get the full Form 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.