FDA Inspection
ECI Pharmaceuticals, LLCECI Pharmaceuticals, LLC – FDA Inspection, Jan 27, 2023
Record Details
This FDA Inspection record concerns ECI Pharmaceuticals, LLC, with an inspection on January 27, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 90aa198d-8a7c-4e8c-9063-8ced8707db0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195706
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(j)Failure to maintain records
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(j)Failure to maintain records
- 21 CFR 314.81(b)(2)Timely submission
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Other FDA inspections of ECI Pharmaceuticals, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2026 | Not classified | Florida District Office | Drug Quality Assurance |
| April 22, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 22, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 8, 2017 | Not classified | Florida District Office | |
| November 18, 2016 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
Other documents for ECI Pharmaceuticals, LLC
- FDA Inspection 1337266 - 2026-09-24
- FDA Inspection 1168612 - 2022-04-22
- FDA Inspection 1084843 - 2019-02-22
- FDA Inspection 1030111 - 2017-08-08
- FDA Inspection 993627 - 2016-11-18
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