# FDA WARNING_LETTER - Sharn, Inc. - August 11, 2011

Source: https://www.keypedia.com/records/warning_letter/sharn-inc/51d5c4d8-fb10-49f1-9b3a-95b04f7c052d

> FDA WARNING_LETTER for Sharn, Inc. on August 11, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sharn, Inc.
- Inspection Date: 2011-08-11
- Product Type: Devices
- Office Name: Florida District Office
- Summary: On December 29, 2011, the FDA issued a Warning Letter to Sharn, Inc. following an inspection from August 10-11, 2011. The inspection found that Sharn, a repacker and relabeler of Class I and Class II medical devices (e.g., Crystaline® II and TempAlert® II Temperature Indicators), was operating in violation of the Federal Food, Drug, and Cosmetic Act.

The devices were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Key violations included:
- Failure to establish and maintain adequate procedures for Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)).
- Inadequate procedures for receiving, reviewing, and evaluating complaints, including determining reportable events under Medical Device Reporting (MDR) (21 CFR 820.198(a)(3)).
- Failure to maintain adequate records of complaint investigations (21 CFR 820.198(e)).
- Inadequate procedures for purchasing control (21 CFR 820.50) and acceptance activities (21 CFR 820.80(a)) for all received products.
- Failure to control noncon

## Related Officers

- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

Company: https://www.keypedia.com/companies/sharn-inc/f57e0f7d-8bfe-4101-9054-44fd7ed5df70

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9