FDA Inspection
Marlin Company, Inc.Marlin Company, Inc. – FDA Inspection, Apr 18, 2012
Record Details
This FDA Inspection record concerns Marlin Company, Inc., with an inspection on April 18, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Marlin Company, Inc.
- Inspection Date
- April 18, 2012
- Product Type
- Drugs
View Company Profile
ID · 20714ce0-052a-46f7-9764-a8fa5d999d14
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 780993
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 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 211.166(a)Lack of written stability program
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.180(e)(1)Review of representative number of batches
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
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 |
| June 11, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Marlin Company, Inc.
- FDA Inspection 937145 - 2015-07-21
- FDA Inspection 589553 - 2009-06-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.