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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-99/
- Published: 2017-02-07T12:00:00.000Z
- Updated: 2026-09-14T22:05:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137923

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

**Berkeley Nutritional Manufacturing Corp.** Livermore, CA (1/31): FDA inspected the firm 2/2016 and documented serious GMP violations for dietary supplement products. FDA also found labeling violations for the Irvingia IGOB-131 + Cissus CQR-300 Weight Management Formula and Magnesium Malate products. FDA said the claims on the product labels establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm539265.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm539265.htm?ref=fdaweb.com)

**HMD Biomedical** Taiwan (Republic of China) (8/31/2016): FDA inspected the firm 3/2016 and documented GMP violations with its GoodLife AC 300-305 Self Monitoring Blood Glucose device. The FDA investigator found that the firm failed to establish and maintain procedures for validating the device design. Additionally, the firm failed to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications where deviations from device specifications could occur as a result of the manufacturing process.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm539946.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm539946.htm?ref=fdaweb.com)

**Implant Dental Technology Co.** Guangdong, China (10/25/2016): FDA inspected the firm 6/2016 and cited the firm for GMP violation associated with its manufacturing of porcelain-fused-to-metal restorations, porcelain restorations, partial dentures and full dentures. For example, the inspection found that the firm failed to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality. Additionally, FDA says it failed to develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications.

**Neo Vision Co.** Wonju-Si, Gangwon-Do 22080, Republic of Korea (9/14/2016): FDA inspected the firm 5/2016 and cited GMP violations involving its manufacturing of daily wear soft contact lenses. For example, the agency investigator found that the firm failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. Also, the inspection cited it for failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm539957.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm539957.htm?ref=fdaweb.com)