FDA Inspection
Elroselabs Inc.Elroselabs Inc. – FDA Inspection, Dec 21, 2017
Record Details
This FDA Inspection record concerns Elroselabs Inc., with an inspection on December 21, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d4158f03-ef76-44c5-a451-3555513aa1d7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1035796
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
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