FDA Intel

Hello Life, Inc

Form 483 issued March 7, 2019 · Kentwood, Michigan

Inspection
Dec 11, 2018 – Mar 7, 2019
Investigators
Alexandra A. Carrico· Charles L. Zhou· Theodore N. Sietsema
Observations
15
Pages
16
FEI number
3009727070

In short: On March 7, 2019, FDA issued a Form 483 with 15 observations to Hello Life, Inc in Kentwood, Michigan (FEI 3009727070) after an inspection that ran Dec 11, 2018 – Mar 7, 2019. The investigators were Alexandra A. Carrico, Charles L. Zhou and Theodore N. Sietsema. Most observations concern dietary supplement CGMP and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).

At a glance

9 of 15 observations on this 483 concern dietary supplement cgmp.

Dietary supplement CGMP9
Quality system4
Laboratory controls2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 111.560(a)(1)

    A qualified person did not review a product complaint to determine whether the product complaint involved…

  2. 02
    21 CFR 111.12

    The personnel you identified to perform quality control operations are not qualified to do so and…

  3. 03
    21 CFR 111.105(b)

    Your quality control personnel did not review and approve the documentation setting forth the basis…

  4. 04
    21 CFR 111.70(e)

    You did not establish product specifications for the identity, purity, strength and composition of the…

11 more observations

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

Get the full 483

This inspection in context

The investigator

Alexandra A. Carrico

2 documents · 2019–2022

Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.

The firm

Hello Life, 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 111.560(a)(1)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Hello Life, Inc?

FDA listed 15 observations on this Form 483, mostly about dietary supplement CGMP, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.

Who inspected Hello Life, Inc?

Alexandra A. Carrico, Charles L. Zhou and Theodore N. Sietsema are named on this Form 483, for the inspection of Dec 11, 2018 – Mar 7, 2019. Each investigator has a profile showing what they cite most.

When was Hello Life, Inc inspected by FDA?

The inspection ran Dec 11, 2018 – Mar 7, 2019, and the Form 483 is dated March 7, 2019.

How do I get the full Form 483 for Hello Life, Inc?

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