FDA Inspection
Marlex Pharmaceuticals, Inc.Marlex Pharmaceuticals, Inc. – FDA Inspection, Nov 14, 2025
Record Details
This FDA Inspection record concerns Marlex Pharmaceuticals, Inc., with an inspection on November 14, 2025, issued by the Philadelphia District Office, covering human drugs.
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ID · 74e7a747-a9b9-407a-b602-9ae03b7a359a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1291594
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.142(b)Storage under appropriate conditions
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Other FDA inspections of Marlex Pharmaceuticals, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 12, 2021 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| 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 1169769 - 2022-04-14
- FDA Inspection 1148584 - 2021-08-12
- FDA Inspection 1028879 - 2017-09-06
- FDA Inspection 931349 - 2015-06-16
- FDA Inspection 741052 - 2011-08-24
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