FDA Inspection
Pharmaceutical Laboratories and Consultants, Inc.Pharmaceutical Laboratories and Consultants, Inc. – FDA Inspection, May 21, 2009
Record Details
This FDA Inspection record concerns Pharmaceutical Laboratories and Consultants, Inc., with an inspection on May 21, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 21, 2009
- Product Type
- Drugs
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ID · 7f105515-df7f-4c55-9198-8af99547b390
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 574204
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Pharmaceutical Laboratories and Consultants, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 |
Other documents for Pharmaceutical Laboratories and Consultants, Inc.
- FDA Inspection 1028257 - 2017-10-10
- FDA Inspection 869173 - 2014-03-06
- FDA Inspection 809917 - 2012-12-13
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