FDA Inspection
Chemco CorporationChemco Corporation – FDA Inspection, Aug 22, 2025
Record Details
This FDA Inspection record concerns Chemco Corporation, with an inspection on August 22, 2025, issued by the Florida District Office, covering human drugs.
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ID · 510cbe3d-4abc-44fd-bf72-06ca971cde59
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1279204
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of Chemco Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 6, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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