FDA WARNING_LETTER - DavisMade, Inc. - March 26, 2008
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
- Office
- Detroit District Office
- Person
ID · 70fc4455-7765-4b77-97e5-27cc91722c10
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