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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-192/
- Published: 2019-04-09T12:00:00.000Z
- Updated: 2026-09-15T01:19:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143827

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

**Apollo Care** Columbia, MO (3/20): FDA inspected the outsourcing facility 11/2018 and cited serious deficiencies in its practices for producing sterile drug products. For example, some of the firm’s drug products did not include required statements on the label, such as the dosage form of the drug, the date that the drug was compounded; and storage and handling instructions. The firm also continued aseptic production within ISO 5 laminar air flow hoods despite identifying multiple HEPA filter leaks within the surrounding ISO 7 cleanroom during certifications. Additionally, Apollo failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area, and aseptic operators had not completed any successful media fills before initiating aseptic production.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635010.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635010.htm?ref=fdaweb.com)

**Cord for Life** Altamonte Springs, FL (3/29): FDA inspected the firm 11/2018 and determined that it processes human umbilical cord blood derived cellular products for allogeneic use, which are considered biological and human cells, tissues, or cellular or tissue-based products. FDA determined that there is no approved BLA or an IND in effect. Additionally, the inspection cited significant GMP deviations. For example, Cord for Life’s unvalidated manufacturing processes, uncontrolled environment, and inadequate personnel aseptic practices pose a significant risk that the products may be contaminated with microorganisms or have other serious product quality defects.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635078.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635078.htm?ref=fdaweb.com)