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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-105/
- Published: 2017-03-21T12:00:00.000Z
- Updated: 2026-09-14T22:12:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138262

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

**ARK Bio-Medical Canada Corp.** North Milton, Prince Edward Island, Canada (3/7): FDA inspected the firm 7/2015 and determined that the firm is marketing the ARK Bio Microwave Plasma Defroster without marketing clearance or approval. The agency said the plasma defroster differs from the originally cleared device — WestLabs Model 601 Blood Plasma Warming Device (BK 870009). FDA said the currently marketed device has new features that require a new premarket notification.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm547175.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm547175.htm?ref=fdaweb.com)

**Jinan Jinda Pharmaceutical Chemistry Co.** Zhangqiu City, Shandong Province, China (2/24): FDA inspected the firm 6/2016 and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, the firm’s quality unit failed to exercise its responsibility to ensure the APIs manufactured at its facility are in compliance. The firm was also cited for failing to adequately investigate out-of-specification results. Additionally, FDA found that the firm’s laboratory systems lacked controls to prevent staff from altering or deleting electronic data; analysts manipulated and deleted audit trails.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm546319.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm546319.htm?ref=fdaweb.com)

**USV Private Limited** Mumbai, India (3/10): FDA inspected the firm 6/2016 and documented significant GMP violations involving finished pharmaceuticals. For example, the firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures. The firm also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. Additionally, USV Private failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records. FDA said the quality system does not adequately ensure the accuracy and data integrity to support the safety, effectiveness, and quality of the drugs the firm manufactures.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm546483.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm546483.htm?ref=fdaweb.com)