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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-174/
- Published: 2018-09-18T12:00:00.000Z
- Updated: 2026-09-15T00:32:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142385

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

**ITG-Medev** San Francisco, CA (9/7): FDA inspected the firm in June and cited GMP deficiencies with its device, the Omiderm wound dressing. For example, the firm failed to ensure processes whose results cannot be fully verified by subsequent inspection and test have been validated according to established procedures. The firm also failed to document device acceptance activities. And the firm failed to establish procedures for implementing corrective and preventive actions.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm620237.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm620237.htm?ref=fdaweb.com)

**Jabones Y Productos** Especializados Guadalajara, Mexico (9/5): FDA inspected the firm in March and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Additionally, the firm failed to conduct at least one test to verify the identity of each component of a drug product.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm619968.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm619968.htm?ref=fdaweb.com)

  
**Pharmaceutical Laboratories and Consultants** Addison, IL (8/29): FDA inspected the contract testing laboratory 10/2017 and cited GMP violations for finished pharmaceuticals. Similar GMP deficiencies were cited during inspections in 5/2007, 5/2009, 12/20112 and 3/2014\. During the recent inspection, FDA said the firm 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. It also lacked scientific data to demonstrate that the microbial limits procedure and test methods used to test customers’ finished OTC drug products and components are suitable and reliable. Additionally, the firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm620002.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm620002.htm?ref=fdaweb.com)