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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-21/
- Published: 2020-05-05T12:00:00.000Z
- Updated: 2026-09-14T16:13:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146725

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

**Bedfont Scientific**, Kent, United Kingdom (2/12): FDA inspected the company 10/2019 and cited GMP issues with its carbon monoxide gas analyzers. For example, Bedfont failed to establish and maintain procedures for validating the device design. It also failed to establish and maintain procedures for implementing corrective and preventive action. Additionally, the company failed to establish and maintain procedures to control product that does not conform to specified requirements. To view the Warning Letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bedfont-scientific-ltd-604311-02122020?ref=fdaweb.com).  

**Philosys Co.**, Gunsan-si, South Korea (1/14): FDA inspected the firm 8/2018 and cited medical device reporting violations for its Self-Monitoring Blood Glucose test systems. For example, Philosys failed to submit a report to FDA no later than 30 calendar days after the day that it received or otherwise became aware of information, from any source, that reasonably suggests that a device may have caused or contributed to a death or serious injury. It also failed to maintain information related to an adverse event, including all documentation of deliberations and decision making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable. To view the Warning Letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/philosys-co-ltd-582516-01142020?ref=fdaweb.com)  

**Shriram Institute for Industrial Research**, Delhi, India (4/15): FDA inspected the firm 10/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records. Additionally, the firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures. FDA said that the inspection cited similar observations cited in an 8/2016 inspection. To view the Warning Letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shriram-institute-industrial-research-597629-04152020?ref=fdaweb.com).