Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-09-02.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Aug 2021 – 2 Sep 2021 | Human Drugs | 483 | View 483 → |
| 11 Dec 2018 – 7 Mar 2019 | Human Drugs | 483 | View 483 → |
| 7 Mar 2017 – 10 Mar 2017 | Human Drugs | WL | View 483 → |
| 28 May 2014 – 4 Jun 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Sep 2021
21 CFR 111.560(a)(1)
Product complaint - quality control review
Cited by Rohn R Robertson, Charles L Zhou, Joseph A Piechocki
2 Sep 2021
21 CFR 111.560(a)(1)
Product complaint - quality control review
Cited by Rohn R Robertson, Charles L Zhou, Joseph A Piechocki
2 Sep 2021
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Rohn R Robertson, Charles L Zhou, Joseph A Piechocki
2 Sep 2021
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Rohn R Robertson, Charles L Zhou, Joseph A Piechocki
2 Sep 2021
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Rohn R Robertson, Charles L Zhou, Joseph A Piechocki
Investigators
FDA investigators tied to this site in the record.
Charles L Zhou3 insp.
Constantin Y Philopoulos2 insp.
Rohn R Robertson1 insp.
Joseph A Piechocki1 insp.
Alexandra A Carrico1 insp.
Theodore N Sietsema1 insp.
Kelley L Clark1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.560(a)(1) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.160(d)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.105(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.12 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.127(h) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.15(k) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.8 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(c)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hello Life, Inc's 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat