FDA WARNING_LETTER - DavisMade, Inc. - March 26, 2008

Record Details

On August 8, 2008, the FDA issued a Warning Letter to DavisMade, Inc. following an inspection from March 12-26, 2008. The inspection revealed that the firm's Standing Dani, Sprout, and Kidster Dani wheel-stand/wheelchairs are adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 C.F.R. Part 820) Current Good Manufacturing Practice (CGMP) requirements.

Key violations include: - Failure to establish and maintain design control procedures (21 C.F.R. 820.30), lacking documentation for Design Input, Output, Review, Verification, Validation, Transfer, and Changes, and an incomplete design history file for the Kidster Dani. - Absence of procedures for corrective and preventive actions (CAPA) (21 C.F.R. 820.100(a)). - No established procedures for receiving, reviewing, and evaluating complaints (21 C.F.R. 820.198(a)). - Failure to control non-conforming product (21 C.F.R. 820.90(a)), with undocumented non-conforming base frames. - Lack of acceptance activity procedures (2

Company: DavisMade, Inc.
Inspection Date: March 26, 2008
Product Type: Devices
Office: Detroit District Office
Person: Joanne M. Givens (Ms.)

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ID · 70fc4455-7765-4b77-97e5-27cc91722c10

Violation Codes10

21 U.S.C. 321(h)21 U.S.C. 351(h)21 CFR 820.3021 CFR 820.100(a)21 CFR 820.198(a)21 CFR 820.90(a)21 CFR 820.8021 CFR 820.50(b)21 CFR 820.200(a)21 CFR 820.181

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