FDA Inspection
Health & Beyond, LLCHealth & Beyond, LLC – FDA Inspection, May 30, 2013
Record Details
This FDA Inspection record concerns Health & Beyond, LLC, with an inspection on May 30, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Health & Beyond, LLC
- Inspection Date
- May 30, 2013
- Product Type
- Drugs
View Company Profile
ID · 4a934d94-965a-4088-b425-c40fe787fb71
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 833514
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
10- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.95(b)(2)Documentation - supplier qualification
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.365Manufacturing operations - prevent contamination
- 21 CFR 111.75(c)Specifications met - verify; finished batch
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