FDA Inspection
Glucorell, Inc.Glucorell, Inc. – FDA Inspection, Aug 7, 2012
Record Details
This FDA Inspection record concerns Glucorell, Inc., with an inspection on August 7, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Glucorell, Inc.
- Inspection Date
- August 7, 2012
- Product Type
- Drugs
View Company Profile
ID · d4918078-55a4-48ac-a83a-db7d5b7b22fe
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 793643
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
7- 21 CFR 111.103Written procedure quality control operations material review
- 21 CFR 111.553Written procedures - product complaint
- 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 111.205(a)Master manufacturing record - each batch
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Glucorell, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2017 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| November 20, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Glucorell, Inc.
- FDA Inspection 1022217 - 2017-07-20
- FDA Inspection 855703 - 2013-11-20
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