FDA Inspection
Marlex Pharmaceuticals, Inc.Marlex Pharmaceuticals, Inc. – FDA Inspection, Aug 12, 2021
Record Details
This FDA Inspection record concerns Marlex Pharmaceuticals, Inc., with an inspection on August 12, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Marlex Pharmaceuticals, Inc.
- Inspection Date
- August 12, 2021
- Product Type
- Drugs
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ID · 02c251e8-dcfd-4b8d-a9a6-664d252ab39d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1148584
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Marlex Pharmaceuticals, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2025 | VAI | Philadelphia District Office | Drug Quality Assurance |
| April 14, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 6, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 16, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 24, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Marlex Pharmaceuticals, Inc.
- FDA Inspection 1291594 - 2025-11-14
- FDA Inspection 1169769 - 2022-04-14
- FDA Inspection 1028879 - 2017-09-06
- FDA Inspection 931349 - 2015-06-16
- FDA Inspection 741052 - 2011-08-24
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