FDA Inspection
KDS Nail ProductsKDS Nail Products – FDA Inspection, Aug 2, 2012
Record Details
This FDA Inspection record concerns KDS Nail Products, with an inspection on August 2, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- KDS Nail Products
- Inspection Date
- August 2, 2012
- Product Type
- Drugs
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ID · 010872c8-c09a-4b5d-ac03-f43e16d9aa69
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 794597
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of KDS Nail Products
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 1, 2012 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for KDS Nail Products
- FDA Inspection 868763 - 2014-03-04
- FDA Inspection 801875 - 2012-10-01
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