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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-33/
- Published: 2020-08-11T12:00:00.000Z
- Updated: 2026-09-14T16:24:28.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147409

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.  
  
**Taka USA**, Carrollton, TX (7/29) FDA inspected the company 6/2019 and cited significant GMP violations for finished pharmaceuticals. For example, Taka failed to have for each batch of drug product an appropriate laboratory determination of satisfactory conformance to final specifications for the drug product. It also failed to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/taka-usa-inc-dba-cosmetic-innovations-587521-07292020?ref=fdaweb.com).

**Soluciones Cosmeticas**, Mexico (8/4): FDA recently conducted testing of drug products manufactured at its facility — Bersih consumer antiseptic hand sanitizer — and determined that the products are adulterated because a substance was substituted wholly or in part. FDA said the substitution demonstrates that the quality assurance within the facility is not functioning according to GMPs. The agency said its testing identified sanitizers containing 1.6% methanol, a dangerous chemical when in contact with human skin or ingested. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/soluciones-cosmeticas-sa-de-cv-609057-08042020?ref=fdaweb.com).