Pentec Health – FDA State Referral Letter, Aug 8, 2016

Record Details

This STATE REFERRAL LETTER record concerns Pentec Health, with an inspection on August 8, 2016, issued by the Office of Health Technology 5 (Neurological and Physical Medicine Devices), covering devices.

Company: Pentec Health
Inspection date: August 8, 2016
Product type: Devices
Office: Office of Health Technology 5 (Neurological and Physical Medicine Devices)
People: Melanie Zimmerman
Robin M. Rivers (Director of Compliance Branch)

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ID · 2ad5ff13-2038-4cd1-b20f-544954ca3c0a

Violation Codes3

21 CFR 20.64(d)(3)21 CFR 20.88FD&C Act 503A(a)

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STATE REFERRAL LETTER

Pentec HealthAugust 8, 2016

Pentec Health – FDA State Referral Letter, Aug 8, 2016

Record Details

Company: Pentec Health
Inspection date: August 8, 2016
Product type: Devices
Office: Office of Health Technology 5 (Neurological and Physical Medicine Devices)
People: Melanie Zimmerman
Robin M. Rivers (Director of Compliance Branch)

View Company Profile

ID · 2ad5ff13-2038-4cd1-b20f-544954ca3c0a

Violation Codes3

21 CFR 20.64(d)(3)21 CFR 20.88FD&C Act 503A(a)

Full citation text and observation details available on the Dashboard.

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

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