FDA Warning Letter for OTC Manufacturer in Arizona

Recommendation

5-8 December 2023

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The U.S. Food and Drug Administration (FDA) has recently published a new Warning Letter dated 01 September 2023. The letter goes back to an inspection performed from 17 to 22 November 2022 at a drug manufacturing facility in Arizona, USA. The firm manufactures over-the-counter (OTC) hand sanitizers.

The authority considers the answer to the Form FDA 483, that preceded the Warning Letter, as "inadequate because it did not provide sufficient detail or evidence of corrective actions to bring [the] operations into compliance with CGMP."

Key Findings

The main deficiencies concern the following areas:

• Lack of a quality unit (QU) to adequately oversee the manufacture of the drug products
• Inappropriate production and process controls
• Inadequate cleaning and maintenance procedures for the equipment
• Inadequate identity testing of incoming components
• Inadequate procedures regarding water specifications, testing, or handling of water.
• Lack of thorough OOS investigations
• Absence of an appropriate stability testing program
• Violations related to unapproved new drugs
• Misbranding of products

The FDA points out that if the company wants to continue CGMP activities, it is responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

For further information, please see the complete Warning Letter to PureChemPros LLCon the FDA website.