FDA WARNING_LETTER - Mc-NEIL-PPC, Inc. - January 19, 2012

FDA WARNING_LETTER for Mc-NEIL-PPC, Inc. on January 19, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Mc-NEIL-PPC, Inc. on January 19, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

21 CFR 803.56

21 U.S.C. 352(t)(2)

21 CFR 820.198(d)

21 U.S.C. 351(f)(1)(B)

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 CFR 820.100(a)(4)

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Record Information

Company

Mc-NEIL-PPC, Inc.

Inspection Date

January 19, 2012

Product Type

Devices

Office

New Jersey District Office

People

Diana Amador-Toro (District Director)

ID: d7a92e0b-aefa-4d50-8c19-7e9a69408dbd

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