Drugs

Repeat CGMP Violations Seen in LiquidCapsule Inspection

FDA says a 6/25-7/3/2025 inspection at the LiquidCapsule Manufacturing drug manufacturing facility in Tampa, FL, found repeated significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/19/2025 Warning Letter says the five specific inspection observations were:

failure to test samples of each component for identity and conformity with all appropriate specifications for purity, strength, and quality, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products;
failure to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced; and
failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, quality, and purity they purport or are represented to possess.

The letter says the firm’s responses to the inspection observations were inadequate. It also notes that a 2/5-2/8/2024 inspection cited similar CGMP observations. “Following a 7/2024 regulatory meeting, you proposed specific remediation to your stability program,” FDA says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

The agency recommends that LiquidCapsule engage a qualified consultant to assist it in meeting CGMP requirements.

The company was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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