FDA Inspection
Acino Products, LLCAcino Products, LLC – FDA Inspection, Oct 26, 2015
Record Details
This FDA Inspection record concerns Acino Products, LLC, with an inspection on October 26, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Acino Products, LLC
- Inspection Date
- October 26, 2015
- Product Type
- Drugs
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ID · 7c6c220e-1a5f-48fc-b76a-85647292d0cf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 949868
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
6- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Acino Products, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2025 | OAI | New Jersey District Office | Drug Quality Assurance |
| August 30, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 12, 2019 | Not classified | New Jersey District Office | Unapproved and Misbranded Drugs |
| November 14, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 22, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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