FDA Inspection 984087 — Bio Answer Holdings, Inc.
The FDA completed an inspection of Bio Answer Holdings, Inc. on August 15, 2016 in Hauppauge, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 15, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15803 | 21 CFR 111.560(c) | Product complaint -investigate, findings, follow-up |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |
| 15834 | 21 CFR 111.70(c)(2) | Specifications identity, purity strength, composition |
| 15874 | 21 CFR 111.75(c)(4) | Documentation - specifications met; basis, quality control |