Nexgen Pharma, Inc
Form 483 issued May 29, 2015 · Rosenberg, Texas
- Inspection
- May 26 – May 29, 2015
- Investigator
- Sonia R. Peterson
- Observations
- 1
- Pages
- 1
- FEI number
- 1643943
In short: On May 29, 2015, FDA issued a Form 483 with 1 observation to Nexgen Pharma, Inc in Rosenberg, Texas (FEI 1643943) after an inspection that ran May 26 – May 29, 2015. The investigator was Sonia R. Peterson. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Sonia R. Peterson
4 documents · 2011–2015
Cites 118.4 (salmonella enteritidis (se) prevention measures) more than any other section. Most of their documents are for sites in California.
The firmNexgen Pharma, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nexgen Pharma, Inc?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Nexgen Pharma, Inc?
Sonia R. Peterson is named on this Form 483, for the inspection of May 26 – May 29, 2015. Each investigator has a profile showing what they cite most.
When was Nexgen Pharma, Inc inspected by FDA?
The inspection ran May 26 – May 29, 2015, and the Form 483 is dated May 29, 2015.
How do I get the full Form 483 for Nexgen Pharma, Inc?
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.