Drugs

Scientific Solutions Global Inspection Violations

A 12/11/18-1/2/19 FDA inspection at the Scientific Solutions Global drug manufacturing facility, Carle Place, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other issues. A just-released 6/28 Warning Letter says specific violations were:

failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release;
failing to conduct at least one test to verify the identity of each component of a drug product, and failing to validate and establish the reliability of the component supplier’s test analyses at appropriate levels;
failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess, and failing to have the quality control unit review and approve the procedures, including any changes;
failing to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA strongly advised that the firm engage a qualified consultant to assist it in meeting CGMP requirements. The letter reminds the company that it is responsible for the quality of its drugs regardless of agreements in place with a contract facility.

A number of the firm’s products are considered unapproved new drugs, FDA also says.

Scientific Solutions was told to respond with a list of actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion.

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