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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-53/
- Published: 2021-02-09T12:00:00.000Z
- Updated: 2026-09-14T16:46:01.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148629

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

**Allay Pharmaceuticals**, Hialeah, FL (1/27) FDA inspected the firm 5/2020 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Allay also failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. To view the Warning Letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/allay-pharmaceuticals-llc-609023-01272021?ref=fdaweb.com).

**Ignacio J. Rodriguez**, Hialeah, FL (1/29): FDA inspected the clinical site 9/2020 and cited objectionable conditions under the agency’s Bioresearch Monitoring Program. For example, the clinical investigator failed to ensure that the investigation was conducted according to the investigational plan. The letter said the agency was unable to determine if the investigator’s written response provided a corrective action plan that, if properly carried out, would prevent this type of violation in the future. Specifically, the agency said it did not provide sufficient details about a plan for implementing additional measures and procedures to address the inspection findings regarding the enrollment of ineligible subjects. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ignacio-j-rodriguez-md-613002-01292021?ref=fdaweb.com).