FDA Inspection
Plastikon Healthcare LLCPlastikon Healthcare LLC – FDA Inspection, Nov 4, 2021
Record Details
This FDA Inspection record concerns Plastikon Healthcare LLC, with an inspection on November 4, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Plastikon Healthcare LLC
- Inspection Date
- November 4, 2021
- Product Type
- Drugs
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ID · 37d35842-244f-488a-b34d-e9ba246a41f3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1156663
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.28(b)Habits of good sanitation & health
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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Other FDA inspections of Plastikon Healthcare LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 12, 2023 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| October 28, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 22, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Plastikon Healthcare LLC
- FDA Inspection 1229941 - 2024-04-30
- FDA Inspection 1195398 - 2023-01-12
- FDA Inspection 990284 - 2016-10-28
- FDA Inspection 858032 - 2013-11-22
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