FDA Inspection
Medical Chemical CorporationMedical Chemical Corporation – FDA Inspection, Aug 16, 2018
Record Details
This FDA Inspection record concerns Medical Chemical Corporation, with an inspection on August 16, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fcf37dc6-3615-4e89-b39c-09374d95da58
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062302
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.80(a)Procedures To Be in Writing
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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 |
| 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 1261268 - 2025-02-18
- FDA Inspection 1241801 - 2024-06-10
- FDA Inspection 1165578 - 2022-03-25
- FDA Inspection 920513 - 2015-02-25
- FDA Inspection 751813 - 2011-10-19
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