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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-29/
- Published: 2020-07-07T12:00:00.000Z
- Updated: 2026-09-14T16:20:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147143

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

**Greiner Bio-One**, Monroe, NC (4/16): FDA inspected the firm 12/2019 and cited GMP violations for its medical device (Vacuette brand blood collection tubes). For example, Greiner failed to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation. Additionally, the company failed to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/greiner-bio-one-north-america-inc-606266-04162020?ref=fdaweb.com).  

**Luminex Corp.**, Austin, TX, (6/26): FDA inspected the company in February and found Quality System Regulation and Medical Device Reporting violations in the firm’s work as a manufacturer of microsphere-based and PCR-based multiplexing systems for in-vitro diagnostic use or life science research use, including software and hardware, reagents, and cassettes. For example, Luminex failed to validate a process when changes or process deviations occurred. It also failed to adequately establish procedures for corrective and preventive action. Additionally, the company failed to adequately establish procedures for performing servicing activities and verifying that servicing meets specified requirements. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/luminex-corporation-606267-06262020?ref=fdaweb.com).  

**Vega Life Sciences**, Telangana, India (6/17): FDA inspected the firm 11/2019 and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, Vega failed to control and monitor solvent recovery procedures to ensure that solvents meet appropriate standards before reuse in API manufacturing. The company also failed to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vega-life-sciences-private-limited-604469-06172020?ref=fdaweb.com).