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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-40/
- Published: 2020-10-06T12:00:00.000Z
- Updated: 2026-09-14T16:31:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147816

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

**Essential Pharmaceutical**, Pomona, CA (9/3): FDA inspected the firm 10/2019 and found that the company produces adulterated and misbranded dietary supplements as well as an unapproved new drug. For example, FDA said the company was manufacturing an unapproved new drug and marketing it as an over-the-counter product. The company also failed to establish identity specifications for each component used in the manufacture of the product. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/essential-pharmaceutical-corp-597677-09032020?ref=fdaweb.com).

**LEC Custom Products**, Ontario, Canada (9/24): FDA inspected the firm in March and cited significant GMP violations for finished pharmaceuticals. For example, LEC failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use. It also failed to establish written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess. To view the letter, click [here](ttps://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lec-custom-products-inc-607838-09242020).