FDA Inspection
Benchmark Medical, Inc.Benchmark Medical, Inc. – FDA Inspection, Dec 13, 2012
Record Details
This FDA Inspection record concerns Benchmark Medical, Inc., with an inspection on December 13, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Benchmark Medical, Inc.
- Inspection Date
- December 13, 2012
- Product Type
- Drugs
View Company Profile
ID · 6a40dbcd-da4f-4fa3-a3f7-8a274e623d18
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 810530
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.184(c)Individual inventory record
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.180(d)Reader/Photocopy equipment not made available
- 21 CFR 211.48(a)Plumbing System Defects
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