United Laboratories Manufacturing, LLC
Form 483 issued August 26, 2016 · Carrollton, Texas
- Inspection
- Aug 22 – Aug 26, 2016
- Investigator
- Patrice S. Hall
- Observations
- 2
- Pages
- 3
- FEI number
- 3006056935
In short: On August 26, 2016, FDA issued a Form 483 with 2 observations to United Laboratories Manufacturing, LLC in Carrollton, Texas (FEI 3006056935) after an inspection that ran Aug 22 – Aug 26, 2016. The investigator was Patrice S. Hall. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.180(e)(2) (1×) · 211.67(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established for evaluations done at least annually and including provisions for a…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Patrice S. Hall
7 documents · 2014–2016
Cites 211.42 (design and construction features) 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 211.180(e)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at United Laboratories Manufacturing, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected United Laboratories Manufacturing, LLC?
Patrice S. Hall is named on this Form 483, for the inspection of Aug 22 – Aug 26, 2016. Each investigator has a profile showing what they cite most.
When was United Laboratories Manufacturing, LLC inspected by FDA?
The inspection ran Aug 22 – Aug 26, 2016, and the Form 483 is dated August 26, 2016.
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.