FDA Inspection
Tri State De Mexico SA De R.L. C.V.Tri State De Mexico SA De R.L. C.V. – FDA Inspection, Dec 6, 2018
Record Details
This FDA Inspection record concerns Tri State De Mexico SA De R.L. C.V., with an inspection on December 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3a0e24eb-02b0-4499-9c37-e7f921957f65
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073906
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of Tri State De Mexico SA De R.L. C.V.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Tri State De Mexico SA De R.L. C.V.
- FDA Inspection 839178 - 2013-06-21
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