FDA Inspection
Keystone Laboratories, Inc.Keystone Laboratories, Inc. – FDA Inspection, Jul 1, 2009
Record Details
This FDA Inspection record concerns Keystone Laboratories, Inc., with an inspection on July 1, 2009, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Keystone Laboratories, Inc.
- Inspection Date
- July 1, 2009
- Product Type
- Food/cosmetics
View Company Profile
ID · 68ec6f2f-9c75-41c1-aad3-408d3b002baf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 597192
- FDA center
- Foods & Cosmetics
- Project area
- Colors and Cosmetics Technology
FDA Citations
18- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.198(a)Adverse Drug Experience
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.25(a)GMP Training Frequency
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Other FDA inspections of Keystone Laboratories, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 5, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 12, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 15, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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