FDA Inspection
Medical Chemical CorporationMedical Chemical Corporation – FDA Inspection, Feb 25, 2015
Record Details
This FDA Inspection record concerns Medical Chemical Corporation, with an inspection on February 25, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Medical Chemical Corporation
- Inspection Date
- February 25, 2015
- Product Type
- Drugs
View Company Profile
ID · 6b62021b-82c6-4972-9b28-c86e5de53f1d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 920513
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
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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 |
| 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 1062302 - 2018-08-16
- FDA Inspection 751813 - 2011-10-19
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