FDA Inspection
Centro NaturistaCentro Naturista – FDA Inspection, Feb 4, 2016
Record Details
This FDA Inspection record concerns Centro Naturista, with an inspection on February 4, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Centro Naturista
- Inspection Date
- February 4, 2016
- Product Type
- Drugs
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ID · 2e253267-6d5e-4d36-a970-6049e06bcd69
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 958350
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
11- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.75(f)(2)Label - visual examination, review supplier"s documentation
- 21 CFR 111.75(g)Packaging, labeling - visual examination
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.70(f)Specifications - product received for packaging, labeling
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.503Written procedures - returned dietary supplement
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - each batch
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