FDA Warning Letters Week of 12/29/2019: Data Integrity and Vendor CoA Reliance

This week, FDA posted three drug warning letters, one of which was issued regarding combination products.  Again, for these warning letters note FDA’s request for “independent” assessments, continuing the pattern they started a while ago.

We also cover a warning letter to a bakery that failed to comply with the [Food] Foreign Supplier Verification Program.  While we don’t routinely cover warning letters issued by CFSAN for foods in these posts, this one is one of a small group issued in 2019 (the third of its type for the year) regarding failure to comply with requirements of the Foreign Supplier Verification Program, so it’s worth mention.  


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DRUG | Cross Brands Contract Filling, LLC

Cross Brands Contract Filling, LLC (Rockledge, FL) received a warning letter on December 17, 2019 based on the outcome of an inspection ending June 10, 2019.  The firm manufactures OTC drug products.

FDA states:  “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.”  FDA specifies actions the firm should take to remediate its data integrity deficiencies.  In addition, the firm is cited for distributing unapproved new drugs.

Deficiencies identified in the warning letter include but are not limited to:

  • Raw materials are received and accepted based on the vendor CoA without testing for identity.
  • The Quality Unit did not provide adequate oversight of manufacturing operations.  The firm did not have written procedures that described manufacturing operations and batch and laboratory records were not complete.
  • Water used in the manufacture of drug products was not subject to a microbiological monitoring program.

DRUG | GPT Pharmaceuticals Private Ltd

GPT Pharmaceuticals Private Ltd (Balanagar, India) received a warning letter on December 17, 2019 based on the outcome of an inspection ending June 28, 2019.

FDA states: “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.”   FDA identifies actions the firm must take to remediate their data integrity issues, and notes that the firm has hired a consultant to assist them in meeting FDA requirements.

The firm also sourced API from a firm that refused an FDA inspection and was subsequently placed on Import Alert.  In response, FDA placed GPT Pharmaceuticals on Import Alert 99-32 until they no longer source drugs from the API supplier who is on import alert.  They also must revise their supplier qualification program.  Additionally, they were placed on Import Alert 66-41 one day before the warning letter was issued.  Deficiencies are associated with OOS investigations, use of problematic solvents (well redacted!), lack of Quality Unit oversight and poor equipment maintenance/cleanliness.

Deficiencies include but are not limited to:

  • The firm did not adequately address OOS events for residual solvent [identity is redacted] used in manufacture of the purchased API.  The firm also did not ensure that assay and impurity methods were validated.  Regarding the OOS for residual solvents, the firm retested and generated passing results, so the API was released.  FDA notes that the solvent(s) in question “…should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity.”
  • Dedicated equipment has visible rust, dents, and scratches on product contact surfaces.  The firm stated they did not verify cleanliness of all surfaces because the equipment train is dedicated.  That clearly isn’t an acceptable approach for FDA.
  • The firm did not exercise adequate controls over computer systems.  The firm demonstrated a pattern of aborted runs and single run entries.  Further, staff used the Agilent Service Account login so all had full administrator privileges and actions could not be associated with a unique individual.  In response to the warning letter, the firm is asked to address the “long” version of FDA requirements for data integrity remediation.

DRUG | Henan Kangdi Medical Devices Co. Ltd

Henan Kangdi Medical Devices Co. Ltd (China) received a warning letter on December 3, 2019 based on the outcome of an inspection ending March 7, 2019.  The firm manufactures OTC drug products and distributes unapproved new drugs according to the warning letter.  The firm manufactures transdermal patch drug products.

Deficiencies include but are not limited to:

  • Drug products are not tested to meet identity and strength specs before being released.  The Quality Unit apparently does not review laboratory and manufacturing data.
  • The firm did not test purchased APIs or other raw materials but rather relied on the vendor CoA.  Further, the results on the CoA have not been confirmed.  The CoAs were not retained and no identity test was performed.  The inspection in 2016 identified failure to perform identity testing and the firm committed to test incoming raw materials.
  • The firm has not established a stability program to ensure the drug products meet specifications through their expiry.
  • In addition to the preceding deficiencies, FDA notes that the firm’s Quality Unit is not fully exercising its responsibilities; previous inspections noted similar GMP deficiencies.  FDA recommends the firm hire a qualified consultant(s) to assist them in coming into GMP compliance and also reminds them that contract manufacturers are considered to be extensions of the manufacturer.

FOOD | El Molino Bakery Suppliers Inc

Foreign Supplier Verification Program:  El Molino Bakery Suppliers Inc (Duluth, GA) received a warning letter on December 16, 2019 based on the outcome of an inspection ending September 12, 2019.  The firm is not in compliance with the Foreign Supplier Verification Program regarding products they import.

The FDA notes they may impose an import alert on the imported items if El Molino Bakery fails to implement a foreign supplier verification program.  The firm did not reply to the FDA form 483 issued at the close of the inspection.  The FDA issued two other warning letters (here and here) in 2019 citing failure to comply with this program.  Two of the warning letters were issued by the Division of Southeast Imports and the third was issued by the Division of Northeast Import.

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