Drugs

Cosmecca Korea Inspection Sees CGMP Issues

A 9/18-9/22/17 FDA inspection at Cosmecca Korea, Chungcheongbuk-do, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/2 Warning Letter. Specific violations cited in the letter 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 ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards;
failing to have the firm’s quality control unit review and approve all drug product production and control records to determine compliance with all established, approved written procedures before a batch is release or distributed;
failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records; and
failing 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.

In the letter, FDA recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements. It also notes that the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. FDA acknowledges the company is using a consultant to audit its data operations and assist in meeting agency requirements.

Cosmecca Korea was placed on an import alert 1/8.

The firm was told to respond with a list of specific steps it has taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome