Bio Answer Holdings, Inc. — FDA Facility Profile
Bio Answer Holdings, Inc. is an FDA-inspected facility (FEI 3004870884) located in Hauppauge, NY, US. RegDataLab tracks 13 FDA inspections and 2 compliance actions at this facility.
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What FDA found at this site
- Latest inspection
- May 5, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 13 (8 VAI, 5 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 2 listed by FDA for this FEI, latest May 5, 2021
- Recalls as the recalling firm
- 2, latest May 13, 2021
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 5, 2025 | Voluntary Action Indicated (VAI) | Standard reference materials; criteria for selecting (21 CFR 111.315(d)) Quality control - batch, product specifications (21 CFR 111.123(b)(2)) Specifications - components (21 CFR 111.70(b)) Specifications - finished dietary supplement (21 CFR 111.70(e)) and 1 more |
| Sep 19, 2022 | Voluntary Action Indicated (VAI) | Criteria for establishing specifications; reviewed, approved (21 CFR 111.315(a)) Quality control - verification requirements, exempted (21 CFR 111.105(e)) Quality control - batch, product specifications (21 CFR 111.123(b)(2)) |
| Jul 27, 2018 | Voluntary Action Indicated (VAI) | Written procedure quality control operations material review (21 CFR 111.103) |
| Sep 9, 2016 | Voluntary Action Indicated (VAI) | Personnel - education, training, experience (21 CFR 111.12(c)) Physical plant - repair (21 CFR 111.15(b)(2)) Manufacturing operations - prevent contamination (21 CFR 111.365) Record - product complaint; findings (21 CFR 111.570(b)(2)(ii)(F)) and 2 more |
| Aug 15, 2016 | No Action Indicated (NAI) | Hold - mix-up, contamination, deterioration (21 CFR 111.455(c)) Packaging description, representative label (21 CFR 111.210(g)) Product complaint - quality control investigate (21 CFR 111.560(a)(2)) Product complaint -investigate, findings, follow-up (21 CFR 111.560(c)) and 3 more |
| Apr 8, 2015 | No Action Indicated (NAI) | No citations listed |
| Apr 1, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
| Aug 10, 2012 | Voluntary Action Indicated (VAI) | Master manufacturing record - each batch (21 CFR 111.205(a)) |
| Jul 30, 2012 | No Action Indicated (NAI) | No citations listed |
| Sep 6, 2011 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 13, 2021 | Class II | F-1000-2022 | NATURE's ANSWER Coral Calcium; Antioxidant Benefits*; 1000mg Coral Calcium per serving… Product contained cesium chloride, a New Dietary Ingredient |
| Sep 9, 2016 | Class II | F-0906-2017 | Liquid VITAMIN D-3 Drops distributed under the following private labels and sizes: a)… The lots exceed the label claim for Vitamin D3 of 2000 IU per drop. |
Facility details
- Company
- Bio Answer Holdings, Inc.
- Location
- Hauppauge, NY (US)
- Source
- inspections