FDA Inspection
ECI Pharmaceuticals, LLCECI Pharmaceuticals, LLC – FDA Inspection, Sep 24, 2026
Record Details
This FDA Inspection record concerns ECI Pharmaceuticals, LLC, with an inspection on September 24, 2026, issued by the Florida District Office, covering human drugs.
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ID · 68180fe4-cdfd-41e9-b6ee-b7d5c523d0c9
Inspection Facts
- Inspection number
- 1337266
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of ECI Pharmaceuticals, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2023 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| 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 1195706 - 2023-01-27
- 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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