FDA Inspection
International Medication Systems Ltd.International Medication Systems Ltd. – FDA Inspection, Feb 9, 2017
Record Details
This FDA Inspection record concerns International Medication Systems Ltd., with an inspection on February 9, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8fae4908-e943-4447-90d7-dd851de23841
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1002629
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of International Medication Systems Ltd.
16| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2025 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| October 2, 2024 | Not classified | Los Angeles District Office | |
| February 15, 2023 | VAI | Los Angeles District Office | |
| May 25, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 16, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for International Medication Systems Ltd.
- FDA Inspection 1296658 - 2025-12-19
- FDA Inspection 1232055 - 2024-10-02
- FDA Inspection 1199252 - 2023-02-15
- FDA Inspection 1170352 - 2022-05-25
- FDA Inspection 1149895 - 2021-07-16
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