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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-57/
- Published: 2021-04-27T12:00:00.000Z
- Updated: 2026-09-14T16:56:29.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149201

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

  
**American Specialty Pharmacy**, Branch, TX (4/5): FDA inspected the outsourcing facility 8/2018 and determined that drugs produced do not meet outsourcing facility requirements. It also noted serious deficiencies in the facility’s practices for producing sterile drug products. For example, the agency says American Specialty failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Additionally, media fills were not performed under the most challenging or stressful conditions such as failing to simulate the largest batch size produced at the facility. To view the Warning Letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/american-specialty-pharmacy-inc-dba-asp-cares-604003-04052021?ref=fdaweb.com).

  
**Exela Pharma Sciences**, Lenoir, NC (4/8): FDA inspected the firm 7/2019 and determined that the drug products produced failed to meet the agency’s outsourcing facility requirements. For example, the facility’s procedures for reporting adverse events are inadequate. Additionally, product labeling fails to bear adequate directions for their intended uses causing them to be misbranded, FDA says. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/exela-pharma-sciences-llc-611316-04082021?ref=fdaweb.com).