FDA Inspection
Zermat Internacional, S.A. de C.V.Zermat Internacional, S.A. de C.V. – FDA Inspection, Oct 14, 2022
Record Details
This FDA Inspection record concerns Zermat Internacional, S.A. de C.V., with an inspection on October 14, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 14, 2022
- Product Type
- Drugs
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ID · 34c62734-011e-4f5e-980b-9bf0258b49b1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1181681
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Zermat Internacional, S.A. de C.V.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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