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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-30/
- Published: 2020-07-21T12:00:00.000Z
- Updated: 2026-09-14T16:21:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147249

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

**Centurion Medical Products**, Williamston, MI (6/11): FDA inspected the company 8/2019 and cited sterile convenience kits that have not been approved or cleared by FDA. The inspection also found that Centurion failed to establish and maintain procedures to control the design of the device to ensure that specified design requirements were met. It also failed to establish and maintain procedures for implementing corrective and preventive actions. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centurion-medical-products-corporation-598837-06112020?ref=fdaweb.com).

**Signa SA de CV facility**, Toluca De Lerdo, Mexico (7/14): FDA inspected the firm 12/2019 and found significant GMP deviations for active pharmaceutical ingredients. The agency says Signa failed to adequately investigate out-of-specification results and to implement appropriate corrective action. The letter also acknowledges that Signa initiated efforts to remediate and improve its investigation programs and says the company response lacked adequate details on the remediation approach and the scope of its assessment was insufficient. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/signa-sa-de-cv-605219-07142020?ref=fdaweb.com).

**Stason Pharmaceuticals**, Irvine, CA (7/8): FDA inspected the firm 10/2019 and found significant GMP violations for finished pharmaceuticals. For example, Stason failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed. It also failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel instituted changes in master production and control records or other records. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stason-pharmaceuticals-inc-604889-07082020?ref=fdaweb.com).