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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-15/
- Published: 2020-03-17T12:00:00.000Z
- Updated: 2026-09-14T16:07:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146349

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

**Cipla Limited**, Mumbai, India (2/25): FDA inspected the company 9/2019 and cited significant GMP violations for finished pharmaceuticals. For example, Cipla failed to clean, maintain, and sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or established requirements. It also failed to thoroughly investigate any discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been distributed. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-597511-02252020?ref=fdaweb.com).

**Gojo Industries**, Cuyahoga Falls, OH (1/17): FDA states that because the firm’s Purell Healthcare Advanced Hand Sanitizer product line is intended for use as consumer and healthcare antiseptics it is considered an unapproved new drug. The letter contains examples of claims from the firm’s Web sites that indicate the products are intended to reduce or prevent disease from the Ebola virus, norovirus, and influenza. The products also are considered to be new drugs because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gojo-industries-inc-599132-01172020-0?ref=fdaweb.com).

**Windlas Healthcare Private Limited**, Dehradun, Uttarakhand, India (3/10): FDA inspected the company 8/2019 and cited significant GMP violations for finished pharmaceuticals. For example, Windlas failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards. It also failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, and labeling. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/windlas-healthcare-private-limited-595494-03102020?ref=fdaweb.com).