FDA Inspection
ScienceLab.Com, Inc.ScienceLab.Com, Inc. – FDA Inspection, Aug 26, 2015
Record Details
This FDA Inspection record concerns ScienceLab.Com, Inc., with an inspection on August 26, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ScienceLab.Com, Inc.
- Inspection Date
- August 26, 2015
- Product Type
- Drugs
View Company Profile
ID · 574820a9-9572-42bb-bf2a-bfb6b5aad7e2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 928538
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.46(c)Exhaust systems inadequate to control air contamination
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
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