FDA Inspection
LEC Custom Products, Inc.LEC Custom Products, Inc. – FDA Inspection, Dec 8, 2017
Record Details
This FDA Inspection record concerns LEC Custom Products, Inc., with an inspection on December 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bcdf8563-a40f-4abd-8bee-82863835d90b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034510
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.101(d)Verification of component addition
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of LEC Custom Products, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 27, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 15, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for LEC Custom Products, Inc.
- FDA Inspection 1120203 - 2020-03-06
- FDA Inspection 922379 - 2015-03-27
- FDA Inspection 760757 - 2011-12-15
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