FDA Warning Letters go to Manufacturers in China, Ireland, Australia and India
In May the US FDA has issued five Warning Letters that address cGMP-violations on a large scale. The drug facilities involved are:
- Jilin Shulan Synthetic Pharmaceutical und Nox Bellcow Cosmetics Co, China
- Jalco Cosmetics, Australia
- Europharma Concepts, Ireland
- Reine Lifescience, India.
The five manufacturers were placed on FDA import alert until the complete correction of all violations. Here are some of the findings:
Jilin Shulan Synthetic Pharmaceutical, China
During the four-day inspection, a number of GMP violations were detected. These included a lack of documentation for deviations, insufficient data-protection controls as well as record-keeping delays during manufacturing operations. Especially the integrity of data and the well functioning of the quality unit were questioned. It was found that operators were able to modify and delete files on the firm’s systems. Therefore, the quality of the manufactured drugs was considered insufficient. It also appeared evident that the staff had no knowledge of GMP.
Jalco Cosmetics, Australia
At least four violations of GMP were imposed on Jalco Cosmetics:
“Your firm failed 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”, the FDA writes.
The manufacturer also failed to establish written procedures for production and process control, equipment qualification and, on top, lacks a process validation program.
The FDA concludes that they “recommend a qualified third party to perform a comprehensive audit of the entire operation for CGMP compliance, including the quality assurance system, materials system, facility and equipment system, laboratory system, production system, and packaging and labeling system. CAPA should then be evaluated by the third party to help ensure systemic remediation before pursuing resolution of your firm’s compliance status.”
Europharma Concepts, Ireland
Using glycerin as an ingredient, the firm failed to analyse lots of glycerin raw material for the presence of diethylene glycol and ethylene glycol prior to releasing it for use in drug product manufacturing. DEG contamination in glycerin has resulted in various lethal poisoning incidents in humans worldwide. Europharma also failed to test incoming active pharmaceutical ingredient and other components of their products and held no such written procedures in place. Those were also missing for production and process controls along with the lack of a process validation program.