Drugs

Dr Retter CGMP Violations Cited

An FDA records review determined that Dr Retter Ec Wladyslaw Retter, Mazowieckie, Poland, which is registered with FDA as a manufacturer of over-the-counter drug products, has significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/14 Warning Letter says specific violations are:

failing 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 to follow all of the written production and process control procedures;
failing to conduct at least one test to verify the identity of each component of a drug product;
failing to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product; 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.

The letter says the firm lacks a process validation program and does not have an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality. FDA recommends that it retain a qualified consultant to audit its entire operation for CGMP compliance and then assist it in meeting CGMP requirements.

All of the firm’s products were placed on a 3/4/22 Import Alert.

The company was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the corrections.

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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