FDA Inspection 726990 — HealthCare Products, Inc.

HealthCare Products, Inc. — FEI 3006073016

The FDA completed an inspection of HealthCare Products, Inc. on May 10, 2011 in Coldwater, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 10, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Coldwater, OH (United States)

Citations

IDCFRDescription
1471121 CFR 820.160(a)Lack of or inadequate procedures for distribution
232821 CFR 820.22Quality audits - auditor independence
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency