FDA Inspection
Acino Products, LLCAcino Products, LLC – FDA Inspection, Jun 12, 2019
Record Details
This FDA Inspection record concerns Acino Products, LLC, with an inspection on June 12, 2019, issued by the New Jersey District Office, covering human drugs.
- Person
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ID · f3d5a2a0-5c05-4732-bd97-7a4871a0999f
Inspection Facts
- Inspection number
- 1092674
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)Written procedures not established/followed
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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 |
| 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 |
| October 26, 2015 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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