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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-113/
- Published: 2017-05-16T12:00:00.000Z
- Updated: 2026-09-14T22:23:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138700

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

**Howard Phillips, LLC** Millerton, OK (5/8): FDA inspected the firm 10/2016 and documented significant GMP violations involving finished pharmaceuticals. For example, FDA said the firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product. In addition, the firm lacked testing for microbial attributes, including absence of objectionable microorganisms, or sterility, where appropriate. And, the firm failed to use equipment constructed to ensure surfaces that contact components, in-process materials, or drug products are not reactive, additive, or absorptive. For example, the inspector observed bulk drug products stored in repurposed household containers, such as bottles for plastic soft drinks, juice, milk, and a cleaning agent.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm557859.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm557859.htm?ref=fdaweb.com)

**International Medsurg Connection**, Schaumburg, IL (5/8): FDA inspected the specifications developer and manufacturer of hypodermic syringes 9/2016 and cited GMP deficiencies. For example, FDA found that procedures for finished device acceptance have not been adequately established. Additionally, it found requirements that must be met by suppliers and contractors have not been adequately established.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558368.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558368.htm?ref=fdaweb.com)

**Oxford Performance Materials**, South Windsor, CT (5/1): FDA inspected the firm in April and cited GMP deviations associated with its manufacture of Osteofab 3D-printed cranial and maxillofacial implants. For example, the firm failed to perform a cleaning validation for certain cranial implants. The firm also failed to adequately document the pre-vacuum sterilization for its implants. And, the firm failed to establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm557872.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm557872.htm?ref=fdaweb.com)  
  
**Vertical Pharmaceuticals** Bridgewater, NJ (5/10): FDA inspected the firm 10/2016 and documented serious violations of the Postmarketing Adverse Drug Experience (PADE) reporting requirements. For example, FDA says the firm failed to develop written procedures for processing postmarketing adverse drug experiences. As a result, the firm these failed to evaluate and submit any 15-day alert reports to the Divigel NDA since 3/2014\. One experience report was 913 days late and was only filed due to the inspection.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558377.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558377.htm?ref=fdaweb.com)

  
**Vidco, Inc.** Beaverton, OR (5/5): FDA inspected the firm in January and cited GMP deficiencies associated with manufactured patient monitoring devices, including the NetViewer MDP2040-0100 device. For example, the firm failed to establish and maintain procedures for validating the device design. The firm also failed to establish and maintain procedures for verifying the device design to confirm that the design output meets the design input requirements.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558078.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558078.htm?ref=fdaweb.com)