FDA Inspection
ECI Pharmaceuticals, LLCECI Pharmaceuticals, LLC – FDA Inspection, Nov 18, 2016
Record Details
This FDA Inspection record concerns ECI Pharmaceuticals, LLC, with an inspection on November 18, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Ileana Barreto-Pettit (Issuing Officer)
- Jennifer Lalama (FDA Associated Person)
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ID · f88d84cc-b551-4e5b-bddd-05b4622a6e13
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993627
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)(3)Mixing adequacy
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures not established/followed
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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 |
| 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 |
Other documents for ECI Pharmaceuticals, LLC
- FDA Inspection 1337266 - 2026-09-24
- FDA Inspection 1195706 - 2023-01-27
- FDA Inspection 1168612 - 2022-04-22
- FDA Inspection 1084843 - 2019-02-22
- FDA Inspection 1030111 - 2017-08-08
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