# FDA WARNING_LETTER - Scottcare Corporation - January 13, 2012

Source: https://www.keypedia.com/records/warning_letter/scottcare-corporation/51523a2a-b3de-4b5c-ac2f-8cb62087d7d1

> FDA WARNING_LETTER for Scottcare Corporation on January 13, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Scottcare Corporation
- Inspection Date: 2012-01-13
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On February 21, 2012, the FDA issued a Warning Letter to Scottcare Corporation following a January 9-13, 2012 inspection of their Westlake, OH facility, which manufactures telemetry devices. The inspection found the devices 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 CFR Part 820).

Violations included:
1.  Failure to establish adequate CAPA procedures for analyzing quality data using statistical methodology to identify nonconforming products or quality problems (21 CFR § 820.100(a)(1)). The firm's procedures lacked details on data analysis frequency and statistical methods, failing to identify recurring issues like "bad SD card" complaints.
2.  Failure to verify CAPA effectiveness (21 CFR § 820.100(a)(4)), with five of eleven reviewed CAPAs lacking effectiveness checks.
3.  Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR § 820.198(a)), as 10 of 11 "non-complaint" records met the definition of a complaint.
4.  Failure to adequately investigate complaints involving possible device failures (21 CFR §

## Related Officers

- [District Director](https://www.keypedia.com/people/paul-j-teitell/5de80a65-d370-4a60-8080-21befa356d9b)

Company: https://www.keypedia.com/companies/scottcare-corporation/cabe25b2-3102-462b-a064-41255f1f42d4

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861