FDA warns firms for CGMP, QSR violations; online retailers cited for selling unapproved drugs

The US Food and Drug Administration (FDA) has cited several manufacturers for failing to conform to current good manufacturing practices (CGMP) and quality system regulation (QSR) requirements. The agency also warned several online retailers for illegally marketing Schedule II stimulants, opioids, and benzodiazepines.

Macsen Drugs

The agency sent a warning letter to Indian drug maker Macsen Drugs last March, stating that it failed to ensure the manufacture of its active pharmaceutical ingredients (API) adhered to CGMP requirements.

FDA said that despite a December 2022 fire impacting some of Macsen's products, the company's quality unit (QU) allowed the products to be distributed in the US. While the company argued that the fire did not impact the products, the agency disagreed.

“Drugs that have been subjected to improper storage conditions, including extremes in temperatures and smoke, are considered adulterated and are not suitable for distribution in the US supply chain,” said FDA. “Further, you do not commit to initiate a market action against the lots your incident report identifies as ‘impacted and degraded.’”

FDA said Macsen's QU failed to ensure that it collected stability data to support their APIs retest or expiry dates and storage conditions. The agency said the company's records failed to show that the quality of its APIs was maintained throughout their expiry period. It also noted that the company had multiple power failures over two years, sometimes lasting up to 40 hours, that could have affected the quality of the products, and did not document the actual conditions in which the products were kept in the event of a power failure.

Shiva Analyticals

FDA also sent a warning letter to the Indian contract testing company Shiva Analyticals earlier this month for failing to comply with CGMP regulations. The agency said the company failed to thoroughly investigate unexplained discrepancies, or batch failures or their components.

“Your firm did not adequately investigate out-of-specification (OOS) results,” said FDA. “Your investigations into laboratory incidents and OOS results lacked adequate scientific rationale to support root cause determinations and did not extend into previously analyzed batches.

“New test results were used as the basis for invalidating OOS results without also performing an adequate root cause investigation,” the agency added.

Furthermore, it said that Shiva did not take adequate corrective action and preventive actions (CAPA) to minimize human errors that led to many laboratory incidents and OOS investigations over three years. The company was also cited for failing to develop adequate written procedures for its QU.

Onkos Surgical

New Jersey-based Onkos Surgical received a warning letter from FDA in July for QSR violations. The agency said the company failed to establish and maintain procedures that ensured its products met quality requirements and CAPA procedures. It was also cited for failing to establish and maintain adequate procedures to validate its device design with regard to risk analysis, and for failing to identify valid statistical techniques to ensure process capability and product characteristics.

FDA also cited Onkos for failing to submit a medical device Report of Correction or Removal due to a risk from its device or a manufacturing violation. As an example, the agency said while the company removed several lots of its ELEOS Limb Salvage System due to the sterile packaging separating and damaged trays and notified customers of the problem, it did not submit a Report of Correction or Removal to FDA as it was required until after it was investigated.

Kabana Skin Care

Colorado-based Kabana Skin Care, which produces over-the-counter (OTC) products, including sunscreen and hand sanitizer, was also handed a warning letter for CGMP violations. FDA said the company failed to test samples of each component to ensure they conformed to manufacturing requirements and failed to validate the reliability of its component supplier’s test analyses. More specifically, the agency said the company did not adequately test the ethanol and glycerin it received from its supplier before using them in manufacturing its products.

"Identity testing for high-risk drug components ethanol and glycerin include a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for methanol or DEG or EG levels, respectively," said FDA. "Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products."

Kabana was also cited for failing to batch-test its final products to ensure they conform to specifications, and its OU failed to ensure its manufacturing practices comply with CGMP. While the company told regulators it would permanently cease manufacturing and distributing its products in the US, FDA said it needed to be notified before the company decided to start manufacturing again.

Online retailers

FDA also sent warning letters to four online drug retailers, including www.d-pharmacy.com, www.plakini-pharma.com, www.portmeds.com, and www.mysteroidsmarket.com, for selling unapproved and misbranded Schedule II stimulants, opioids, and benzodiazepines.

"There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs," said FDA. "Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight.

"Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether," the agency added.

FDA told all the retailers to cease marketing their products immediately.

Warning letters

FDA warns firms for CGMP, QSR violations; online retailers cited for selling unapproved drugs

Related topics

Recommended content

Welcome to the new RAPS Digital Experience