It is 2020, do you know what your vendors/suppliers/contract manufacturing organizations are doing?

Companies that use contract manufacturing organizations (CMOs) are ultimately responsible for ensuring product quality and compliance with GMPs. Thus, it pays in more ways than one to be aware of recent FDA quality-related citations at CMOs and other vendors.

Below is a sample of FDA observations pulled from recent Warning Letter summaries. Special thanks to Govzilla’s Barbara Unger for summarizing these.

Stason Pharmaceuticals

On July 8, FDA issued a Warning Letter to Stason Pharmaceuticals, a contract development and manufacturing organization specializing in clinical trial materials and products under preparation for commercial launch, with, as Barb described, “the most granular list of requested data integrity remediation activities that I’ve seen FDA provide, to date.” The Warning Letter was issued following an Oct. 9-25 inspection.

Investigators cited two major issues: failure to thoroughly investigate batch records and data integrity. For the latter, lack of appropriate controls for ensuring only authorized changes to production and control records served as a major focus. In particular, the investigators found that a computer operating a spectrophotometer used for finished product release and stability testing was not secured and data files could potentially be deleted without the awareness of the quality unit.

Homeocare Laboratories Inc.

While OTC homeopathic product manufacturer Homeocare Laboratories is not a contract manufacturing organization/supplier, their June 22 Warning Letter included a citation regarding the use of unapproved vendors.

FDA cited the company for not qualifying suppliers nor testing incoming raw materials and components although said materials and components were accepted on the supplier Certificate of Analysis. During the actual inspection, the firm stated that vendors had not actually completed the vendor survey yet in response to the resulting 483, the firm indicated that surveys had been completed.

Vega Life Sciences Private Limited

FDA issued a Warning Letter dated June 17 to Vega Life Science Private Limited, a contract solvent recovery facility for manufacturing APIs. Additionally, the FDA issued an import alert for the firm preventing it from conducting solvent recovery operations for the U.S. market.

In addition to data integrity concerns centered on shared passwords, missing raw data, failure to back up data, and inadequate audit trail management, investigators cited failures to evaluate impurities and inadequate cleaning procedures. Notably, investigators found that cleaning procedures were insufficient to prevent carryover, or “contamination for non-dedicated equipment used to recover spent solvents.”

Here, FDA recommended the firm conduct an extensive data integrity remediation and hire a qualified CGMP consultant.

Samchundang Pharm Co. Ltd.

A Warning Letter was issued May 13 for Samchundant Pharm Co. Ltd. This site functions as both a contract manufacturer and manufactures the company’s own products.

A number of the deficiencies cited in the Warning Letter fell under failure to follow SOPs or inadequate SOPs. Test methods, notably sterility tests and stability tests, were not established as suitable. The suitability of the in-process bioburden test was also not determined. Investigators deemed the systems for environmental monitoring in the aseptic area inadequate, and the company failed to ensure that personnel involved in manufacturing had the relevant education, training, and experience to perform their tasks.

In the end, the company ceased production of product for the U.S. market.

International Trading Pharm Lab Inc

Contract testing laboratory International Trading Pharm Lab received a Warning Letter on April 24. This Warning Letter cited numerous quality testing and data integrity failures. In addition to concerns about access and controls for computerized systems, investigators found that retests had been conducted and these second sets of data were not recorded.

This Warning Letter included a recommendation the company hire a qualified consultant for data integrity remediation and also encouraged quality personnel review FDA’s data integrity guidance.

For a more detailed analysis of this Warning Letter, click here.

Kumar Organic Products Limited

An inspection ending Nov. 14 led to a Warning Letter issued for Kumar Organic Products Limited on April 23. Kumar Organic Products produces an API that serves as an in-process material for a finished drug product. FDA highlighted two main areas of concern: deficiencies in the water system that could potentially enable biofilm formation and failure to test the identity of incoming components nor validate/establish the reliability of supplier data.

FDA recommended the firm hire a qualified CGMP consultant to assist in remediation efforts.

[NOTE: Stay on top of your vendor quality! Get your FREE 483 Observation Report and find out if any of your vendors have received 483 observations. Learn more here.]