FDA Inspection
Nitrox, Inc.Nitrox, Inc. – FDA Inspection, Apr 19, 2010
Record Details
This FDA Inspection record concerns Nitrox, Inc., with an inspection on April 19, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Nitrox, Inc.
- Inspection Date
- April 19, 2010
- Product Type
- Drugs
View Company Profile
ID · 2d07f348-8149-44f9-9afa-26d739767a40
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 659397
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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