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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-111/
- Published: 2017-05-02T12:00:00.000Z
- Updated: 2026-09-14T22:21:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138591

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**Criticare Technologies** North Kingstown, RI (4/21): FDA inspected the firm in March and cited it for GMP violations related to its patient vital sign monitors. For example, FDA said it found 1,385 complaints received since 1/2016 that were still open and not investigated. Six out six complaint records reviewed during the inspection revealed that the firm failed to document required complaint information, including the nature and details of the complaint, and whether a patient was harmed. Additionally, FDA said the firm failed to establish and maintain procedures for implementing corrective and preventive actions.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554586.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554586.htm?ref=fdaweb.com)

**Organ Recovery Systems** Itasca, IL (4/20): FDA inspected the firm in February and cited it for GMP violations related to devices manufactured, including the Kidney Perfusion Solutions, Static Preservation Solutions, Kidney Transporter and disposable perfusion kits. For example, FDA found that the results of design validation were not adequately documented in the design history file. Additionally, FDA said procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.

[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm555755.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm555755.htm?ref=fdaweb.com)

**Sal Pharma** Hyderabad, India (4/20): FDA inspected the firm 7/2016 and found GMP problems associated with its active pharmaceutical ingredient (API) manufacturing. For example, FDA said the firm failed to transfer all quality or regulatory information received about the API to its customers. The firm also failed to re-label and hold APIs under appropriate GMP controls. Additionally, the agency recommended that the firm retain a GMP consultant to evaluate its operations and assist it in meeting GMP requirements.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554775.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554775.htm?ref=fdaweb.com)

**Unetixs Vascular** North Kingstown, RI (4/25): FDA inspected the firm and its manufacturing of vascular diagnostic ultrasound systems and documented significant good manufacturing practice violations. For example, FDA observed over 1,400 complaints received since 1/2015 that were still open and had not yet been investigated. Additionally, FDA said the firm opened 12 corrective and preventive action reports since 2015, and seven of these were reviewed during the inspection. All seven were missing required documentation, such as an analysis of processes or work operations to identify potential causes of quality problems.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm555115.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm555115.htm?ref=fdaweb.com)