FDA Inspection
AV Industries, Inc.AV Industries, Inc. – FDA Inspection, Aug 13, 2009
Record Details
This FDA Inspection record concerns AV Industries, Inc., with an inspection on August 13, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- AV Industries, Inc.
- Inspection Date
- August 13, 2009
- Product Type
- Drugs
View Company Profile
ID · 75998f13-1a7c-4578-922a-0b1f0edd3f82
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 606511
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.170(b)(3)Retention time for some OTC drugs
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.22(a)Lack of quality control unit
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