FDA Inspection
Medical Chemical CorporationMedical Chemical Corporation – FDA Inspection, Aug 31, 2010
Record Details
This FDA Inspection record concerns Medical Chemical Corporation, with an inspection on August 31, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Medical Chemical Corporation
- Inspection Date
- August 31, 2010
- Product Type
- Biologics
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ID · e4c9ef32-7457-4e08-8740-18d43887e7ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 678362
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
12- 21 CFR 820.80(e)Documentation
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 211.130(e)Packaging line inspection documentation
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
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Other FDA inspections of Medical Chemical Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2025 | OAI | Los Angeles District Office | Drug Quality Assurance |
| 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 |
Other documents for Medical Chemical Corporation
- FDA Inspection 1261268 - 2025-02-18
- FDA Inspection 1241801 - 2024-06-10
- FDA Inspection 1165578 - 2022-03-25
- FDA Inspection 1062302 - 2018-08-16
- FDA Inspection 920513 - 2015-02-25
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