FDA sends warning letters to Lupin, Amazon and Walmart

The US Food and Drug Administration (FDA) last month warned Indian generic drugmaker Lupin Limited over three good manufacturing practice (GMP) violations at its facility in Maharashtra, India.

The warning letter stems from an inspection conducted in March and April 2022 that identified issues with the company’s written procedures for equipment cleaning, its written procedures for monitoring and controlling performance of processing steps and the “failure to investigate all critical deviations.”

FDA said the company “performed multiple risk assessments with the purpose to verify whether existing cleaning procedures and practices eliminate or reduce genotoxic impurities … generated through the manufacture of [redacted] drugs after you detected [redacted] impurities in your [active pharmaceutical ingredient] API.” The company also performed risk assessments to determine whether its cleaning procedures reduced the risk of cross-contamination of intermediates and API. However, FDA said the risk assessments “lacked data to support that existing equipment cleaning procedures are effective in removing [redacted] along with residual API from each respective piece of equipment to acceptable levels.

“The identification of genotoxic impurities in quantities near their established limits suggests excursions are possible. All intermediates and API manufactured on non-dedicated equipment used to manufacture [redacted] drugs should be subject to validated sampling and analytical testing to ensure they are not contaminated with unacceptable levels of genotoxic impurities,” FDA said.

FDA also wrote that the company failed to establish written procedures to monitor the progress and control the performance of processing steps that could result in quality variations in its intermediates and API. The agency noted that while the firm’s “benchtop data suggests your purging is effective, your commercial manufacturing data shows your purging does not remove all genotoxic impurities to a consistent level. FDA said that the company must either add a test for the impurity or its precursors upstream or add a test for the impurity to the drug substance specification.

Lastly, FDA said that Lupin “failed to identify and investigate all critical deviations, including limit excursions.”

FDA notes in the warning letter that the firm has committed to suspend the production of drugs destined for the US market until the deviations are addressed.

Undeclared drug ingredients

FDA also sent warning letters to Amazon, Walmart and a San Jose, CA based firm Latin Foods Market last week for distributing products that contain undeclared drug ingredients, including diclofenac and dexamethasone.

All three of the warning letters reference a product called “Atri King Reforzado con Ortiga y Omega 3,” which the agency said contained undisclosed diclofenac, a non-steroidal anti-inflammatory (NSAID) that was verified through laboratory testing of samples purchased through the companies’ websites.

In its warning letter to Latin Foods Market, FDA also said the product contained undisclosed dexamethasone, a corticosteroid. The agency’s letter to Amazon also listed a second product, “Ortiga Mas Ajo Rey,” which the agency said also contained diclofenac.

Both drug ingredients carry health risks and may interact with other medications.

The warning letter comes months after Latin Foods Market issued a voluntary recall for one lot of Artri King Reforzado Con Ortiga Y Omega 3 due to the presence of undeclared diclofenac and dexamethasone. The agency also previously issued a public notice warning consumers not to purchase or use Artri or Ortiga products due to the risk posed by undeclared drug ingredients.

In the case of Amazon and Walmart, FDA notes that both companies distributed the product directly to US consumers on behalf of third parties through the companies’ respective fulfillment services.

FDA sends warning letters to Lupin, Amazon and Walmart

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