FDA Inspection
Medical Chemical CorporationMedical Chemical Corporation – FDA Inspection, Feb 18, 2025
Record Details
This FDA Inspection record concerns Medical Chemical Corporation, with an inspection on February 18, 2025, issued by the Los Angeles District Office, covering human drugs.
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ID · c182aee2-7058-48ed-aac6-286b4d33bc68
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1261268
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of Medical Chemical Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 25, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 16, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 19, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Medical Chemical Corporation
- FDA Inspection 1241801 - 2024-06-10
- FDA Inspection 1165578 - 2022-03-25
- FDA Inspection 1062302 - 2018-08-16
- FDA Inspection 920513 - 2015-02-25
- FDA Inspection 751813 - 2011-10-19
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