FDA Intel

Natren Inc.

Form 483 issued November 2, 2023 · Westlake Village, California

Inspection
Oct 30 – Nov 2, 2023
Investigator
Heidy C. Perales
Observations
3
Pages
4
FEI number
2024261

In short: On November 2, 2023, FDA issued a Form 483 with 3 observations to Natren Inc. in Westlake Village, California (FEI 2024261) after an inspection that ran Oct 30 – Nov 2, 2023. The investigator was Heidy C. Perales. Most observations concern materials and laboratory controls.

At a glance

Materials and laboratory controls account for 2 of 3 observations.

Materials1
Laboratory controls1
Quality system1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.84(a)

    Each lot of components and drug product containers is not withheld from use until the lot…

  2. 02
    21 CFR 211.166(c)(1)

    There is no written assessment of stability of homeopathic drug products based at least on testing…

  3. 03
    21 CFR 211.22(a)

    The quality control unit lacks the responsibility and authority to approve and reject all components, drug…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Heidy C. Perales

5 documents · 2021–2023

Cites 211.160(b) (general requirements) more than any other section. Most of their documents are for sites in California.

The firm

Natren Inc. history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.84(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Natren Inc.?

FDA listed 3 observations on this Form 483, mostly about materials, laboratory controls and quality system. The opening words of each observation are shown on this page.

Who inspected Natren Inc.?

Heidy C. Perales is named on this Form 483, for the inspection of Oct 30 – Nov 2, 2023. Each investigator has a profile showing what they cite most.

When was Natren Inc. inspected by FDA?

The inspection ran Oct 30 – Nov 2, 2023, and the Form 483 is dated November 2, 2023.

How do I get the full Form 483 for Natren Inc.?

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