FDA Warning Letters Week of 11/3/2019: Lost Documentation and Data Integrity

This is yet another week with a preponderance of warning letters issued by the Center for Tobacco Products.  One OTC manufacturer in China received a warning letter and we cover that below.

In addition, Zydus Cadila reported that the FDA issued a warning letter to their Moraiya, India site, though this isn’t posted on the FDA website yet.  This is based on a 23-page form 483 issued in May 2019.  The FDA investigators included Thomas Arista and Justin Boyd. The site manufactures sterile parenteral products.

 

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DRUGS | Bingbing Pharmaceutical Co., Ltd

Bingbing Pharmaceutical Co., Ltd (China) received a warning letter on October 3, 2019 based on the outcome of an inspection ending May 10, 2019.  The firm manufactures OTC products and was placed on import alert 66-40 on August 22, 2019.  The firm also was instructed on how to conduct the data integrity remediation including reference being made to the FDA guidance on this topic.

Deficiencies include but are not limited to:

  • The firm “lost” GMP documentation including test records, retain samples stability samples and batch records when they moved from the facility in Wuhan to the one in Hubei in May 2018.
  • Product is distributed without testing for identity and strength of each active ingredient
  • The Quality Unit did not provide adequate oversight, and they provide six detailed examples.
    • FDA stated, “In your response, you admitted that due to cash flow problems you ‘were unable to ensure all products were completely tested and ensure conformance with all pre-determined specification prior to being shipped out’.”
  • The firm did not keep adequate and accurate records of complaints.

 

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