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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-122/
- Published: 2017-07-18T12:00:00.000Z
- Updated: 2026-09-14T22:34:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139160

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

**Center for Reproductive Health/ Joliet IVF LLC** Crest Hill, IL (7/6): FDA inspected the firm in February and cited deviations from the regulations governing human cells, tissues, and cellular and tissue-based products. For example, FDA said the firm failed to determine whether a donor is eligible based upon the results of donor screening. The firm also failed to retain records that are accurate, indelible, and legible. Additionally, the firm failed to establish and maintain procedures for all steps performed in testing, screening, and determining donor eligibility.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm566407.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm566407.htm?ref=fdaweb.com)

**ChemRite CoPac** Lannon, WI (5/29): FDA inspected the firm 7/2016 and cited GMP deviations with its drug manufacturing. For example, the firm failed to maintain adequate separate defined areas necessary to prevent contamination or mix-ups. The firm also failed to have, for each batch of drug product, appropriate laboratory testing.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm566852.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm566852.htm?ref=fdaweb.com)

**National Biological Corp.** Beachwood, OH (7/11): FDA inspected the firm in March and cited GMP deviations. For example, FDA said it failed to validate a process whose results cannot be fully verified by subsequent inspection and test. The inspection also found that the firm failed to establish and maintain procedures that address the identification, documentation, evaluation, segregation, and disposition of nonconforming product.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm566621.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm566621.htm?ref=fdaweb.com)

  
**Tubilux Pharma SpA** Rome, Italy (7/6): FDA inspected the firm 12/2016 and cited significant GMP violations. For example, the firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably. The firm also failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm566429.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm566429.htm?ref=fdaweb.com)