Posted 18 January 2018
By Zachary Brennan
The five warning letters sent from the US Food and Drug Administration (FDA) in December and January and released this week deal with violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals and active pharmaceutical ingredients (APIs).
Shanwei Honghui Daily Appliance
Following an FDA inspection of the Shanwei, China-based facility in July and August, agency inspectors noted “filling machines used to manufacture over the counter (OTC) drug products for the U.S. market were filthy and were surrounded by cardboard and dirty rags.”
The firm was also warned for having no test records to support the release of drug products for the US market.
“Your engineer and quality assurance supervisor stated that no microbiology tests were performed, there was no record of pH testing, and that the concentration of active ingredients such as [redacted] and [redacted] were not determined. You stated that some tests were sent to a contract testing laboratory. However, you did not provide any test reports during the inspection,” FDA said.
The company also told FDA “there was not a batch record for each batch.”
Following a five-day FDA inspection last March of the Somersby, Australia-based site, FDA found Delta failed to thoroughly investigate release and stability testing failures concerning two batches of a drug product.
“For example, you found tubes swelling at the 3-month stability time point. You did not investigate this significant defect, which can be indicative of microbial growth and spoilage,” the letter said.
FDA also said that Delta lacked adequate process validation studies, did not have adequate stability data and failed to provide an adequate response to the agency on taking corrective actions to bring operations into full compliance.
The Changzhou, China-based API manufacturing site was cited by FDA for failing to use separate facilities to manufacture two products that were redacted from the warning letter. FDA said the site’s practices “demonstrate an unacceptably high risk” of API cross-contamination.
Yicheng also failed to have repackaging batch records and lacked documentation or procedures to ensure that each batch can be traced from API suppliers, among other violations. FDA placed the company on Import Alert 66-40 on 11 August 2017.
Wuhan Chinese Moxibustion Technology
The Wuhan, China-based manufacturer was cited by FDA for lacking an adequate quality control unit and product-specific master production and control records.
“For example, your quality control unit did not adequately review completed production records prior to drug product release,” FDA said.
Following an inspection last July at the company’s Salzburg, Austria-based site, FDA found the firm lacked an adequate quality control site. The firm also did not prepare any master production records or batch production records for its drug.
Shanwei Honghui Daily Appliance Co., Ltd. 12/5/17
Delta Laboratories Pty Ltd 12/19/17
Yicheng Chemical Corp. 1/2/18
Wuhan Chinese Moxibustion Technology Dev. Co., Ltd. 12/18/17
Schrofner Cosmetics Gmbh 12/20/17