FDA Inspection
Keystone Laboratories, Inc.Keystone Laboratories, Inc. – FDA Inspection, Aug 15, 2013
Record Details
This FDA Inspection record concerns Keystone Laboratories, Inc., with an inspection on August 15, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Keystone Laboratories, Inc.
- Inspection Date
- August 15, 2013
- Product Type
- Drugs
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ID · 2b7f06f8-9cfe-4791-977a-0068996b3cca
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 846286
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
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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 29, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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