FDA WARNING_LETTER - 3CPM Company Inc - November 06, 2009
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On March 25, 2010, the FDA issued a Warning Letter to 3CPM, Inc., following an inspection from September 28 to November 6, 2009, which found their electrogastrogram (EGG) devices to be adulterated and misbranded.
The devices were deemed adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820). Key violations included: * **Design Control Deficiencies:** Failure to establish and maintain adequate procedures for design requirements (21 CFR 820.30(c)), design output documentation (21 CFR 820.30(d)), formal design reviews (21 CFR 820.30(e)), design verification (21 CFR 820.30(f)), design validation (21 CFR 820.30(g)), and control of design changes (21 CFR 820.30(i)). Specific examples cited include lack of procedures and documentation for EGG machine versions and software upgrades, and unapproved labeling. * **Quality System Failures:** Inadequate documentation of corrective and preventive actions (21 CFR 820.10
ID · 34c2f086-dd76-42de-aba3-148d6996e7ed
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