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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-201/
- Published: 2019-07-09T12:00:00.000Z
- Updated: 2026-09-15T01:36:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144490

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.  
  
**Akorn**, Lake Forest, IL (6/13): FDA inspected the firm 8/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. Akorn also failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records. Additionally, it failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/akorn-inc-568173-06132019?ref=fdaweb.com).

**AllerQuest**, Plainville, CT (6/24): FDA inspected the firm 1/31 to 3/1 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups. Additionally, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/allerquest-llc-578557-06242019?ref=fdaweb.com).

**Clinicon Corp**., Oceanside, CA (6/20): FDA inspected the firm in April and cited GMP deficiencies with its medical devices. For example, process validation activities and results have not been adequately documented and adequately approved. FDA also found that equipment calibrations, inspections, checks, and maintenance activities have not been documented. Additionally, the firm failed to document the evaluation of potential suppliers and contractors. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/clinicon-corp-582801-06202019?ref=fdaweb.com).

**Izeen Pharma**, Frederick, MD (5/16): FDA inspected the firm 7/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. Additionally, the firm failed to establish adequate written procedures for production and process controls designed to assure that drug products 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/izeen-pharma-inc-565311-05162019?ref=fdaweb.com).

**U.S. Pharmaceuticals**, Belleville, NJ (6/6): FDA inspected the firm 12/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. It also failed to use equipment that has an appropriate design, and adequate size. Additionally, the company failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-pharmaceuticals-inc-573233-06062019?ref=fdaweb.com).