FDA WARNING_LETTER - Home Care Technologies USA, Inc. - August 18, 2011
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On February 9, 2012, the FDA issued a Warning Letter to Home Care Technologies USA, Inc. following an inspection from August 15-18, 2011. The inspection revealed the firm imports and relabels a powered muscle stimulator, classified as a device under 21 U.S.C. § 321(h).
The device was deemed adulterated under 21 U.S.C. § 351(h) due to Quality System regulation violations (21 CFR Part 820), including: 1. Failure to establish purchasing controls (21 CFR 820.50). 2. Failure to establish complaint handling procedures (21 CFR 820.198(a)). 3. Failure to maintain Device Master Records (DMRs) (21 CFR 820.181). 4. Failure to establish Device History Record (DHR) procedures (21 CFR 820.184). 5. Failure to establish labeling control procedures (21 CFR 820.120).
The device was also misbranded under 21 U.S.C. § 352(t)(2) for failure to develop and implement Medical Device Reporting (MDR) procedures (21 CFR 803.1
ID · 7a77d94f-6dc3-4feb-937d-fd22215f4e32
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