FDA Inspection
LEC Custom Products, Inc.LEC Custom Products, Inc. – FDA Inspection, Mar 6, 2020
Record Details
This FDA Inspection record concerns LEC Custom Products, Inc., with an inspection on March 6, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- LEC Custom Products, Inc.
- Inspection Date
- March 6, 2020
- Product Type
- Drugs
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ID · 914129da-50ed-4dac-b781-97f689aa7e95
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1120203
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
22- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.80(d)Identification of Each Lot in Each Shipment
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of LEC Custom Products, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2017 | VAI | 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 1034510 - 2017-12-08
- FDA Inspection 922379 - 2015-03-27
- FDA Inspection 760757 - 2011-12-15
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