Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-05.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Apr 2025 – 5 May 2025 | Foods & Cosmetics | 483 | View 483 → |
| 7 Sep 2022 – 19 Sep 2022 | Foods & Cosmetics | 483 | View 483 → |
| 2 Jul 2018 – 27 Jul 2018 | Foods & Cosmetics | 483 | View 483 → |
| 2 Apr 2015 – 8 Apr 2015 | Foods & Cosmetics | WL | |
| 30 Jul 2012 | Not recorded | Clean | |
| 26 Aug 2011 | Not recorded | 483 | View 483 → |
| 5 Nov 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 May 2025
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Meredith P Soehl, Jung K Kim
5 May 2025
21 CFR 111.205(b)(1)
Master manufacturing record - specifications, quality; packaging, labeling
Cited by Meredith P Soehl, Jung K Kim
5 May 2025
21 CFR 111.315(d)
Standard reference materials; criteria for selecting
Cited by Meredith P Soehl, Jung K Kim
5 May 2025
21 CFR 111.70(e)
Specifications - finished dietary supplement
Cited by Meredith P Soehl, Jung K Kim
Investigators
FDA investigators tied to this site in the record.
Wayne J Meyer2 insp.
Meredith P Soehl1 insp.
Jung K Kim1 insp.
Christopher S Fields1 insp.
Yuyan Liang1 insp.
Tara K Normandin1 insp.
Kwong P Lee1 insp.
Thomas J Mooney1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.105(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.315(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.605(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bio Answer Holdings, Inc.'s 4 Form 483s
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