FDA Inspection
Body Systems Inc.Body Systems Inc. – FDA Inspection, Oct 19, 2012
Record Details
This FDA Inspection record concerns Body Systems Inc., with an inspection on October 19, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Body Systems Inc.
- Inspection Date
- October 19, 2012
- Product Type
- Drugs
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ID · dac67408-7fd0-40b1-89f9-48e6de21adbc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 803702
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
7- 21 CFR 111.70(a)Specifications - manufacturing process
- 21 CFR 111.430(b)Records - packaging, labeling operations
- 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.140(b)(1)QC ops; written procedures; material review, disposition
- 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
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