Drugs

‘Significant’ CGMP Violations at World Perfumes

A 5/5-5/9 FDA inspection at the World Perfumes drug manufacturing facility in Opa-Locka, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/29 Warning Letter says the specific violations were:

failure to conduct at least one test to verify the identity of each component of the drug product (noting that there are products containing ethanol and products containing ingredients at risk for diethylene glycol or ethylene glycol contamination; and
failure to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance, and 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.

FDA says some of the over-the-counter products the company manufactures may be regulated as cosmetics and would have to meet those statutory and regulatory requirements. It says that significant findings in the letter demonstrate that World Perfumes does not have an effective quality system in accord with CGMP. “In addition to the lack of effective management oversight of your production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities,” FDA says. “Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.”

The agency reminds World that it is responsible for the quality of the drugs it produces as a contractor and recommends that it engage a qualified consultant to assist it in meeting CGMP requirements.

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

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