FDA Inspection
Pharmaceutical Laboratories and Consultants, Inc.Pharmaceutical Laboratories and Consultants, Inc. – FDA Inspection, Oct 10, 2017
Record Details
This FDA Inspection record concerns Pharmaceutical Laboratories and Consultants, Inc., with an inspection on October 10, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 10, 2017
- Product Type
- Drugs
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ID · 210a8bda-58ae-494a-b9b7-ec2b73bdf6c7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1028257
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
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Other FDA inspections of Pharmaceutical Laboratories and Consultants, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 21, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pharmaceutical Laboratories and Consultants, Inc.
- FDA Inspection 869173 - 2014-03-06
- FDA Inspection 809917 - 2012-12-13
- FDA Inspection 574204 - 2009-05-21
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