Inadequate Analytical and Microbiological Controls - FDA Warning Letter to Indian Company

The US Food and Drug Administration (FDA) has identified serious violations of Current Good Manufacturing Practice (CGMP) regulations during a review of documents submitted by Akron Formulations India Private Limited, a manufacturer of OTC products. The concerned manufacturing methods and controls result in the produced drugs being considered adulterated under the FD&C Act.

The Warning Letter's main findings

1. Quality control deficiencies:

• No effective quality control unit (QU) with sufficient authority established.
• Inadequate qualification of active pharmaceutical ingredient (API) suppliers, including those that were under FDA import warnings for the US at the time of manufacture, e.g. due to lack of control of water used or refusal of FDA inspections.
• Lack of control and inspection of raw materials and components.

2. Laboratory control deficiencies:

• Lack of laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans and testing procedures.
• Lack of testing for microbiological contamination, particularly for Burkholderia cepacia complex (BCC), a known organism of concern.
• Inadequate antimicrobial efficacy testing (AET) for multi-dose products.
• Lack of specifications to ensure microbiological quality e.g. when manufacturing/storing at room temperature.

3. Manufacturing and recall problems:

• Back in October 2024, OneLAX Docusate Sodium Liquid Stool Softener was recalled due to CGMP violations.

FDA requirements

The FDA is mandating a comprehensive review and improvement of the company's quality systems, including:

• Strengthening the quality control unit.
• Establishment and validation of suitable laboratory controls.
• Perform detailed risk analyses of potential microbial contamination and implement risk mitigation measures.
• Develop a comprehensive remediation plan to comply with CGMP regulations.

The company is also strongly encouraged to engage qualified CGMP consultants and conduct a comprehensive audit of its systems.

Consequences

As long as the violations are not remedied, the FDA reserves the right to refuse further imports and marketing authorizations of products from the company. In addition, inspections are scheduled to verify the implementation of the required measures.

The FDA has placed the company's products for import into the United States on Import Alert 66-40 on November 26, 2024.

Further details can be found directly in the FDA's Warning Letter to Akron Formulations.