The letter – issued October 30, 2017 – responds to the US Food and Drug Administration’s (FDA) five-day inspection of the firm’s Zhangjiang City, Guangdong Province, China-based manufacturing facility in May of this year.
According to the Agency, the finished formulations company failed to identify the active ingredients in its drug products.
“Your firm failed to test your drug products for identity and strength of active ingredients prior to release and distribution,” said the FDA.
The letter also states Guangdong Zhanjiang Jimin Pharmaceutical failed to validate manufacturing processes.
“You did not perform process performance qualification studies, and lacked an ongoing programme for monitoring process control to ensure stable manufacturing operations and consistent drug delivery,” said the Agency.
The company’s response – dated August 16, 2017 – to the FDA’s inspection observations was inadequate, said the FDA.
“Based upon the nature of the violations, we strongly recommend engaging a consultant…to assist your firm in meeting cGMP [current good manufacturing practice] requirements,” said the Agency.
Unapproved & misbranded
The Agency also flagged the firm’s Piyanping Anti-Itch Lotion, designed to “temporarily relieve itching associated with minor skin irritations, inflammation, and rashes,” as an unapproved, and misbranded drug product.
The FDA said it found the product’s label – which says it contains 1% hydrocortisone as its active ingredient – to be incorrect.
“During the FDA inspection conducted May 15-19, 2017, our investigator reviewed the batch record and finished product testing record for Piyanping Anti-Itch Lotion and noted dexamethasone acetate as the active ingredient in this product,” said the Agency.
“When our investigator questioned your firm about the discrepancy between active ingredients from the label versus batch and finished product testing records, they were told that there was a translation mistake where firm management had thought hydrocortisone was the same materials as dexamethasone,” the FDA added.
The product has not received drug application approval from the FDA, and as a result marketing the product in the US is prohibited, said the Agency.
“Piyanping Anti-Itch Lotion, as formulated and labelled, is a ‘new drug’…because it is not generally recognised among scientific experts as safe and effective for uses described in its labelling,” it said.
The firm’s Shennong Analgesic Plaster was also found to contain 1.4% active ingredient methyl salicylate, which is below the proposed External Analgesic Tentative Final Monograph (TFM) dosage range of 10-60%, said the Agency.
Guangdong Zhanjiang Jimin Pharmaceutical has 15 working days to respond to the letter, from the date of issue.