United Laboratories Manufacturing, LLC
Form 483 issued April 9, 2018 · Carrollton, Texas
- Inspection
- Mar 26 – Apr 9, 2018
- Investigators
- Nimmy Mathews· Shelby N. Marler
- Observations
- 8
- Pages
- 5
- FEI number
- 3006056935
In short: On April 9, 2018, FDA issued a Form 483 with 8 observations to United Laboratories Manufacturing, LLC in Carrollton, Texas (FEI 3006056935) after an inspection that ran Mar 26 – Apr 9, 2018. The investigators were Nimmy Mathews and Shelby N. Marler. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
5 of 8 observations on this 483 concern production.
Most cited: 21 CFR 211.188 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written production and process control procedures are…
- 02
Batch production and control records for each batch of drug product produced do not include an…
- 03
The batch production and control records are deficient in that they do not include in-process…
- 04
Test devices are deficient in that insttuments not meeting…
This inspection in context
Nimmy Mathews
5 documents · 2017–2020
Cites 211.113 (control of microbiological contamination) 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 211.188
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 production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected United Laboratories Manufacturing, LLC?
Nimmy Mathews and Shelby N. Marler are named on this Form 483, for the inspection of Mar 26 – Apr 9, 2018. Each investigator has a profile showing what they cite most.
When was United Laboratories Manufacturing, LLC inspected by FDA?
The inspection ran Mar 26 – Apr 9, 2018, and the Form 483 is dated April 9, 2018.
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.