Week of August 25th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This week, there were two warning letters issued to pharmaceutical firms.  But first, we address an EIR associated with AveXis and the second warning letter issued to a firm for failure to comply with the Food Foreign Supplier Verification Program.

I missed this EIR when it published Aug 15, 2019 on the FDA ORA Reading Room.  This EIR is associated with the FDA PAI of the AveXis site in San Diego, CA in February 2019.  Note that this inspection occurred before AveXis and Novartis notified FDA of the data manipulation situation.  No form 483 was issued at the PAI.  This is in contrast to the following inspection ending August 2, 2019 after AveXis and Novartis communicated the data problems where four observations were identified in the form 483.  On July 26, 2019 Wilson Bryan MD, Director of Office of Tissues and Advanced Therapies wrote a memo following up on the report of data manipulation from AveXis / Novartis.  Note that this memo preceded the August inspection addressed earlier in this paragraph.

While we don’t cover this one here, FDA posted the 2nd warning letter to a firm for failure to comply with the requirements of the Food Foreign Supplier Verification Program and its implementing regulations 21CFR1 Subpart L.  Agroson’s LLC in Bronx, New York received the warning letter after an inspection on August 12, 2019.  The speed with which the letter was issued speaks to the risk to public health caused by the deficiencies.  This warning letter is associated with outbreaks of Salmonella in 2019 involving whole, fresh papaya.  The warning letter cites failures in this area as far back as 2011 along with the most recent contamination events.


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DRUGS | CTX Lifesciences Private Ltd.

CTX Lifesciences Private Ltd. (Gujarat, India) received a warning letter on July 12, 2019 based on the outcome of an inspection ending February 16, 2019.  The firm manufactures APIs.  The deficiency in OOS management is identified as something that was identified at previous inspections.

GMP violations include but are not limited to:

  • The firm failed to ensure the water used in manufacture of their API is adequate for the intended use of the API in sterile product.  Endotoxin content is not monitored.
  • The firm invalidated an OOS for related substances result that was included in the pending drug application.  No scientific justification was provided.  All activities, including the one on which the invalidation is based, is not documented.
    • FDA states: “A possible laboratory error is insufficient to close an investigation at Phase (b)(4).  Whenever an investigation lacks conclusive evidence of laboratory error, a thorough investigation of potential manufacturing causes must be performed.”

DRUGS | Ningbo Pulisi Daily Chemical Products Co., Ltd

Ningbo Pulisi Daily Chemical Products Co., Ltd (Zhejiang Shen, China) received a warning letter on August 13, 2019 based on the outcome of an inspection ending February 28, 2019.  The firm makes hand sanitizers and other OTC ‘spa’ type of products.

In addition to the GMP deficiencies, the firm’s products are misbranded because they are deemed to be ‘drugs’ and labeling does not meet requirements.  The FDA also concludes that the Quality Unit is not able to fully exercise its authority and responsibility and references the firm to the FDA guidance on the topic.  The firm was placed on import alert 66-40 on June 10, 2019.

GMP violations include but aren’t limited to the following:

  • Drug product is released without testing for identity of each active ingredient along with testing for microbial attributes.  The firm stated they performed testing at a contract lab consistent with what was required by their customer.
  • The firm did not test incoming raw materials including APIs.  The only attributes evaluated were appearance and smell.  FDA enumerates the inadequacies in their response.
  • The firm did not have adequate stability data to support the three year expiry.
  • The firm did not validate the manufacturing process and have no documented evidence of the same.  FDA refers them to the guidance on process validation.


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