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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-35/
- Published: 2020-08-25T12:00:00.000Z
- Updated: 2026-09-14T16:26:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147513

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.  
  
**Banco Vida Corp.**, San Juan, Puerto Rico (8/12): FDA inspected the firm 9/2019 and cited significant deviations from current good manufacturing practice and current good tissue practice regulations for human umbilical cord blood for allogenic use. For example, Banco Vida failed to screen a donor of cells or tissue by reviewing the donor’s relevant medical records for risk factors. It also failed to adequately establish and follow written procedures designed to prevent microbiological contamination of its cord blood intermediate used to manufacture drug products purporting to be sterile. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/banco-vida-corp-606288-08122020?ref=fdaweb.com).

**Custom Nutraceuticals**, Commack, NY (8/6): FDA inspected the firm in January and found significant violations of current good manufacturing practice regulations for dietary supplements. For example, the firm failed to verify that the finished batch meets product specifications for identity, purity, strength, and composition. it also failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel for using criteria for selecting standard reference materials used in performing tests and examinations. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/custom-nutraceuticals-llc-606293-08062020?ref=fdaweb.com).

**Wintac Limited**, Bangalore, India (8/13): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, Wintac failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. It also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wintac-limited-606700-08132020?ref=fdaweb.com).