FDA Inspection
CMIC CMO USA CorporationFDA Inspection 1037369 - CMIC CMO USA Corporation - January 11, 2018
Record Details
This FDA Inspection record concerns CMIC CMO USA Corporation, with an inspection on January 11, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- CMIC CMO USA Corporation
- Inspection Date
- January 11, 2018
- Product Type
- Drugs
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ID · 21352b2a-996f-47d0-9f29-54d6fdc3cec7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037369
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.100(a)Absence of Written Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CMIC CMO USA Corporation
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2024 | Not classified | New Jersey District Office | |
| March 31, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 4, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 13, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 4, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for CMIC CMO USA Corporation
- FDA Inspection 1244346 - 2024-07-02
- FDA Inspection 1207736 - 2023-03-31
- FDA Inspection 1141200 - 2021-05-04
- FDA Inspection 913702 - 2015-02-13
- FDA Inspection 858664 - 2013-12-04
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