FDA Inspection
Chemco CorporationChemco Corporation – FDA Inspection, Feb 12, 2019
Record Details
This FDA Inspection record concerns Chemco Corporation, with an inspection on February 12, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d513899f-a2bb-431d-9387-29000adf2609
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1079075
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.198(b)Written complaint record to be maintained at facility
- 21 CFR 211.188(a)Accurate reproduction included
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Chemco Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2025 | OAI | Florida District Office | Drug Quality Assurance |
| March 6, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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