Among the eleven warning letters posted this week are three of interest. One was issued to an API manufacturer and two were issued to finished drug product manufacturers. All three firms are located outside the US.
- Alchymars ICM SM Private Limited (Chennai, India) received a warning letter on February 16th 2018 based on the outcome of an inspection ending September 15th 2017. The firm manufactures APIs. The warning letter identifies practices that were repeat observations from an inspection in February 2015, identified again in the 2017 inspections. FDA recommends the firm engage a qualified consultant to help them come into CGMP compliance and acknowledge that the firm has employed a data integrity consultant to conduct assessments. PharmaCompass reports that the site is controlled by Trifarma in Italy who itself received a warning letter in 2014 for data integrity deficiencies. Deficiencies in this warning letter include but are not limited to:
- The firm falsified laboratory data. For example, the investigator noted that the cfu found on bioburden plates testing water differed from the number recorded on the official reports. Also, no growth was documented for plates where the investigator observed growth. The firm commits to suspend production of at least two APIs until remediation is complete. FDA asks to be notified before the firm resumes production and identifies five actions that the firm is to address in their response to the warning letter.
- The investigator identified damaged gaskets in product contact areas of multi-product manufacturing equipment. At least two damaged gaskets were wrapped in peeling tape. Deteriorating gaskets were the root cause of complaints regarding particles found in the API.
- The Quality unit did not adequately investigate complaints. For example, an OOS result registered as a complaint was deemed to be “minor and unjustified” without a thorough review of the event.
- The equipment washroom was identified as being in a “filthy condition with damaged tiles and standing water.”
- The firm did not provide convenient, fully functional handwashing stations.
- Data Integrity Remediation required by FDA includes ‘Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter, provide the following.
- A comprehensive investigation into the extent of the inaccuracies in data records and reporting, including results of the data review for products distributed to the United States.
- A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity, and risks posed by ongoing operations.
- A management strategy for your firm that includes the details of your global corrective action and preventive action plan.’
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- Nowcos, Ltd (Seoul, Korea) received a warning letter on February 14th 2018 based on the outcome of an inspection ending August 4th 2017. This is another example of FDA’s continued focus on OTC products and firms in South Korea. The firm was placed on import alert 66-40 on December 27th 2017. Deficiencies include but are not limited to:
- Manufacturing processes are not validated and ongoing process control monitoring is not conducted.
- Test methods are not validated and sampling plans for raw materials and finished products have not been established.
- The firm has not conducted cleaning validation.
- Stability studies are inadequate to ensure that products retain quality attributes thru their expiry dating.
- Shanghai Weierya Daily Chemicals Factory (Shanghai, China) received a warning letter on February 7th 2018 based on the outcome of an inspection ending April 14th 2017. And this is yet another firm that manufactures OTC products and is also a contract manufacturer. The firm was placed on import Alert 66-40 on September 14th 2017.
- Batches of the final product were released without testing for the total microbial count and objectionable microorganisms. The firm tested one lot every six months, not all lots that were released.
- The firm tested only a subset of incoming API ingredients, not all received shipments.
- The Quality Unit was not performing their responsibilities including a review of batch product records, approval of raw material plus packaging/labeling materials.
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About the Author
Barbara W. Unger formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.
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