FDA Inspection
Lakeshore Technologies IncLakeshore Technologies Inc – FDA Inspection, Feb 22, 2010
Record Details
This FDA Inspection record concerns Lakeshore Technologies Inc, with an inspection on February 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lakeshore Technologies Inc
- Inspection Date
- February 22, 2010
- Product Type
- Devices
View Company Profile
ID · eb6c7548-fac4-478c-91a0-93d9d97a061e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 649466
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.200(d)(6)Test and inspection data
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.