FDA Inspection
Marlin Company, Inc.Marlin Company, Inc. – FDA Inspection, Jun 11, 2009
Record Details
This FDA Inspection record concerns Marlin Company, Inc., with an inspection on June 11, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Marlin Company, Inc.
- Inspection Date
- June 11, 2009
- Product Type
- Drugs
View Company Profile
ID · 8431bf76-48dd-4eed-8ba6-81aca5051813
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 589553
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.101(d)Verification of component addition
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Marlin Company, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 18, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Marlin Company, Inc.
- FDA Inspection 937145 - 2015-07-21
- FDA Inspection 780993 - 2012-04-18
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