Drugs

Gadal Laboratories CGMP Violations

A 2/13-2/17 FDA inspection at Gadal Laboratories in Miami, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/15 Warning Letter says specific violations were:

failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
failure of the firm’s quality control unit to review and approve written procedures for production and process control, including any changes to them, designed to ensure that the drug products Gadal manufactures have the identity, strength, quality, and/or purity they purport or are represented to possess; and
failing to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures.

FDA says the findings in the Warning Letter demonstrate that Gadal does not operate an effective quality system in following CGMP. It also says the quality unit is not fully exercising its authority and/or responsibilities. “Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality,” FDA says.

The agency strongly recommends that Gadal retain a qualified consultant to assist it in meeting CGMP requirements.

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

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