Hello Life, Inc
FDA inspection history in Kentwood, Michigan, 2017 to 2019
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one warning letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19One warning letter and one Form 483, at Kentwood, Michigan.
Cited most
Across all Hello Life observations on file
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 111.105(b)What must quality control personnel do?1
- 21 CFR 111.12What personnel qualification requirements apply?1
- 21 CFR 111.123(a)(1)What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?1
- 21 CFR 111.127(h)What quality control operations are required for packaging and labeling operations?1
The complete Hello Life file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Kentwood, Michigan
One Form 483 and one warning letter · 2017 to 2019 · 15 observations
Latest: Form 483, Mar 7, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-03-07 | 483 Form 483 | Kentwood, Michigan | 15 | $99 |
| 2017-08-07 | Warning letter Warning letter | Kentwood, Michigan | — | $99 |
Investigators on these documents
Alexandra A. Carrico (1)Charles L. Zhou (1)Theodore N. Sietsema (1)
FEI number 3009727070 · most recent document Mar 7, 2019
About Hello Life, Inc
How many FDA Form 483s has Hello Life, Inc received?
FDA Intel has 1 Form 483 on file for Hello Life, Inc; the most recent is dated Mar 7, 2019.
When was Hello Life, Inc last inspected by FDA?
The most recent FDA inspection document on file for Hello Life, Inc is a Form 483 dated Mar 7, 2019, for the site in Kentwood, Michigan.
What did FDA cite at Hello Life, Inc?
The regulations cited most in the observations on file for Hello Life, Inc are 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times; 21 CFR 111.105(b) (What must quality control personnel do?), 1 time; 21 CFR 111.12 (What personnel qualification requirements apply?), 1 time.
Has Hello Life, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hello Life, Inc; the most recent is dated Aug 7, 2017.