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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-104/
- Published: 2017-03-14T12:00:00.000Z
- Updated: 2026-09-14T22:11:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138201

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

**Badrivishal Chemicals & Pharmaceuticals** Maharashtra, India (3/2): FDA inspected the firm 8/2016 and cited significant GMP deviations for manufactured active pharmaceutical ingredients (API). For example, FDA investigators found that the firm’s water purification system was not adequately monitored and controlled. Additionally, the inspection cited the quality unit over documents related to the API manufacturing. Investigators found a large number of trash bags behind a building that contained torn original laboratory and production records, such as analytical test reports, water testing reports, and sample notebooks. The information on these discarded, torn documents did not match the official records.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545454.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545454.htm?ref=fdaweb.com)

**Lumis Global Pharmaceuticals Co.** Wuhan, Hubei, China (3/2): FDA inspected the firm 9/2016 and cited GMP deviations related to active pharmaceutical ingredient (API) manufacturing. For example, the firm failed to transfer all quality or regulatory information received from the API manufacturer to certificates of analysis it issued to customers. The inspection also cited the firm for failing to control the API repackaging, relabeling, and holding operations in order to avoid mix ups and loss of API identity. Additionally, the firm was cited for shipping drugs from a manufacturer on FDA import alert.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545464.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545464.htm?ref=fdaweb.com)