> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-38/
- Published: 2020-09-22T12:00:00.000Z
- Updated: 2026-09-14T16:29:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147709

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.  
  
**Coupler Enterprises**, Warrington, PA (9/15): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals. For example, Coupler failed to inspect the packaging and labeling facilities immediately before use to assure that all drug products have been removed from the previous operations. It also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/coupler-enterprises-607662-09152020?ref=fdaweb.com).

**HNC Products**, Clinton, IL (9/10): FDA inspected the firm in March and cited significant GMP violations for finished pharmaceuticals. For example, HNC 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 has already been distributed. It also failed to establish adequate 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](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hnc-products-inc-607359-09102020?ref=fdaweb.com).