Drugs

CGMP Violations at Lexia LLC

David McFarland

— 1 min read
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A 9/23-9/29/2025 FDA inspection at the Lexia LLC drug manufacturing facility in Franklin, TN, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/7 Warning Letter says that during the inspection, company officials indicated that they would not continue to manufacture drug products and have discontinued their FDA registration. “We received your correspondence dated 11/26/2025, accepting the observations made during the inspection and reiterating your decision to discontinue production of drug products,” FDA writes.

FDA says the violations seen during the inspection were:

  • failure to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release, and failure to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms;
  • failure to conduct at least one test to verify the identity of each component of a drug product, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
  • failure to assure that the drug products bear an expiration date that is supported by appropriate stability testing;
  • failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
  • failure to establish an adequate quality unit, and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

FDA recommends that Lexia engage a qualified consultant to assist it in meeting CGMP requirements. It acknowledges the firm’s statement that it is ceasing production of over-the-counter drugs and reminds Lexia that the agency is to be notified if the company decides to resume production.

Lexia was told to correct 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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