In a broad enforcement action, the U.S. Food and Drug Administration (FDA) issued several warning letters to manufacturers and online retailers for serious violations of current good manufacturing practices (CGMP), Quality System Regulation (QSR), and federal drug marketing laws. The agency cited failures in quality assurance, product testing, and distribution practices that could pose significant risks to patient safety.
Macsen Drugs: API Stability and Distribution Concerns
Indian pharmaceutical manufacturer Macsen Drugs was cited for distributing active pharmaceutical ingredients (APIs) that may have been compromised by a facility fire in December 2022. The FDA stated that the company’s quality unit (QU) allowed these products to be released despite the potential for smoke and heat exposure.
The agency emphasized that drugs exposed to improper storage conditions are considered adulterated. Macsen also failed to initiate a market action for affected batches and did not collect sufficient stability data to support expiration dates and storage conditions. Additionally, the company experienced multiple extended power failures over a two-year period but failed to document the storage conditions during these outages.
Shiva Analyticals: Inadequate OOS Investigations
Contract testing lab Shiva Analyticals, also based in India, received a warning for not thoroughly investigating out-of-specification (OOS) results. FDA inspectors found that the company invalidated OOS results without performing adequate root cause analyses and failed to investigate potentially affected previously tested batches.
The FDA also noted insufficient corrective and preventive actions (CAPA) and inadequate written procedures for the quality unit. The agency flagged repeated laboratory errors and poor documentation practices that spanned several years.
Onkos Surgical: QSR and Reporting Failures
New Jersey-based Onkos Surgical received a warning letter for multiple QSR violations. The company failed to maintain validated design procedures, implement effective CAPA processes, and use proper statistical methods for process and product validation.
Onkos was also cited for failing to notify the FDA about the removal of defective lots of its ELEOS Limb Salvage System. Although the company informed customers of packaging defects, it did not file the required Report of Correction or Removal until after the FDA initiated an investigation.
Kabana Skin Care: Component Testing and Final Product Validation
Kabana Skin Care, a Colorado-based OTC product manufacturer, was warned for failing to test incoming materials such as ethanol and glycerin for hazardous contaminants like methanol and diethylene glycol. These ingredients are considered high-risk and require identity testing under United States Pharmacopeia (USP) standards.
The company also failed to batch-test its final products and did not validate its supplier’s testing methods. While Kabana stated it would cease manufacturing and distribution, the FDA noted that it must be notified before any future production resumes.
Online Retailers: Unapproved and Misbranded Drug Sales
The 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. These platforms were found selling unapproved and misbranded Schedule II stimulants, opioids, and benzodiazepines.
According to the FDA, such products pose serious risks, including contamination, inconsistent potency, and counterfeit ingredients. The agency ordered all four retailers to immediately cease marketing these products.
Supporting Compliance Across Regulated Industries
These enforcement actions reinforce the FDA’s ongoing focus on protecting public health through strict compliance with manufacturing, testing, and marketing regulations. Failures in CGMP, QSR, and drug approval pathways can result in significant cregulatory consequences and public health risks.
At EMMA International, we work with companies across pharmaceuticals, medical devices, and cosmetics to implement robust quality systems and navigate FDA expectations. Whether you need help preparing for inspections, responding to warning letters, or improving compliance programs, our team provides strategic and operational support.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
Al-Faruque, F. (2025, July 31). FDA warns firms for CGMP, QSR violations; online retailers cited for selling unapproved drugs. Regulatory News.
