Natren Inc.
Form 483 issued October 8, 2019 · Westlake Village, California
- Inspection
- Oct 3 – Oct 8, 2019
- Investigator
- Taichun Qin
- Observations
- 2
- Pages
- 3
- FEI number
- 2024261
In short: On October 8, 2019, FDA issued a Form 483 with 2 observations to Natren Inc. in Westlake Village, California (FEI 2024261) after an inspection that ran Oct 3 – Oct 8, 2019. The investigator was Taichun Qin. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 2 of 2 observations.
Most cited: 21 CFR 211.160(a) (1×) · 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Established laboratory control mechanisms are not documented at…
- 02
Deviations from written production and process control procedures are…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmNatren Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Natren Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Natren Inc.?
Taichun Qin is named on this Form 483, for the inspection of Oct 3 – Oct 8, 2019. Each investigator has a profile showing what they cite most.
When was Natren Inc. inspected by FDA?
The inspection ran Oct 3 – Oct 8, 2019, and the Form 483 is dated October 8, 2019.
How do I get the full Form 483 for Natren 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.