FDA Inspection 1312586 - Tessy Plastics Corp. - April 16, 2026

Record Details

This FDA Inspection record concerns Tessy Plastics Corp., with an inspection on April 16, 2026, issued by the New York District Office, covering medical devices & rad health.

Company: Tessy Plastics Corp.
Inspection Date: April 16, 2026
Product Type: Medical Devices & Rad Health
Office: New York District Office
Person: Matthew D. Schnittker (Issuing Officer)

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ID · 943bee18-0abd-48d4-90d9-1da78a21d96a

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1312586
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued, view the record

FDA Citations

ISO 13485:2016 Clause 6.3Requirements for infrastructure maintenance activities not documented
ISO 13485:2016 Clause 6.4.1Work environment requirements and procedures not documented

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FDA Inspection

Tessy Plastics Corp.April 16, 2026