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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-108/
- Published: 2017-04-11T12:00:00.000Z
- Updated: 2026-09-14T22:17:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138422

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

**Indoco Remedies Ltd.** Verna, Goa, India (3/27): FDA inspected the firm’s drug manufacturing facility 9/2016 and cited GMP violations related to its finished pharmaceuticals. For example, the firm failed to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product. The firm also failed to ensure that the responsibilities and procedures applicable to its quality control unit were followed. Additionally, FDA noted that it had cited Indoco Remedies for similar violations during a 2011 inspection, and it recommended that the firm retain a GMP consultant to assist it in meeting GMP requirements.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm550321.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm550321.htm?ref=fdaweb.com)

**Mylan Pharmaceuticals** Canonsburg, PA (4/3): FDA inspected the firm’s Maharashtra, India facility 9/2016 and cited significant GMP violations involving finished pharmaceuticals. For example, Mylan failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. Also, it failed to establish an adequate quality control unit with the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they were fully investigated. Additionally, FDA said the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. It acknowledged that Mylan is using a consultant to audit its operations and assist in meeting FDA requirements.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm550326.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm550326.htm?ref=fdaweb.com)