Warning Letters Week Of 9/13/2020: Lack of Validation

Last week, the FDA posted two warning letters to pharmaceutical firms. One, issued to an OTC manufacturer and API repackager, highlighted product released to the market without a batch record. The other, issued to a homeopathic drug manufacturer, cited a lack of validation in critical areas.

Drug Warning and Untitled Letters

Kalchem International, Inc. 

Kalchem International, Inc. (Lindsay, OK) received a Warning Letter on August 27, 2020, based on the outcome of an inspection ending February 21, 2020. The firm manufactures OTC products and repackages APIs. In addition to the GMP violations, the firm distributes unapproved and misbranded drugs. Deficiencies include but are not limited to:

• The firm shipped product prior to receiving the CoA from the contract laboratory. Further, batch records were not reviewed and approved several weeks later. FDA deemed the firm’s response inadequate because they did not describe the corrective and preventive actions to ensure all batch testing is reviewed prior to release.
• The Quality Unit failed to ensure the repackaged APIs met CGMP requirements. For example, there is no procedure for relabeling APIs, and frequently there is no documentation for the process.

Mayon’s Pharmaceuticals Pvt Ltd

Mayon’s Pharmaceuticals Pvt Ltd (India) received a Warning Letter on September 4, 2020, based on the outcome of an inspection ending February 20, 2020. The firm manufactures homeopathic materials and homeopathic drug products and was placed on import alert 66-40 on July 13, 2020. Deficiencies include but are not limited to:

• Failure to test incoming components for at least identity, nor were suppliers qualified.
• The firm released a drug product containing toxic ingredients without validating the manufacturing process. FDA deemed the response inadequate because it did not include a timeline or detailed plan.  
• The [probably] water system is inadequate to produce adequate quality [water]. The system includes dead legs, visible dripping, and threaded piping. 
• Homeopathic API materials: unidentified debris was identified in equipment used to process multiple raw materials even though the equipment was identified as, “clean.”
• Failure to have cleaning procedures. Plus, cleaning methods are not validated.

Device Warning and Untitled Letters

There were none this week.

BIMO, GCP and GLP Warning and Untitled Letters

There were none this week.

Compounding Pharmacy / Outsourcing Facilities

There were none this week.