Chinese firm warned for making OTC eye drops without microbiological safeguards

Regulatory NewsRegulatory News | 12 January 2022 |  By 

The US Food and Drug Administration (FDA) warned Chinese drugmaker Hubei Kangzheng for having inadequate microbiological controls to prevent contamination of its over-the-counter (OTC) eye drops. These violations partly stem from the firm’s misguided notion that the eye drops are non-sterile drugs, thus not to more stringent microbiological controls.
The warning letter was issued on 23 November 2021 and posted to FDA’s website on 11 January. It follows a nine-day inspection of the company’s Hubei, China facility last June.
FDA cited a litany of good manufacturing practice (GMP) violations tied to the manufacturing of an OTC drug product “pi yen chin” ophthalmic eye drops, which are intended to relieve redness.
According to FDA, the company “failed to demonstrate” that its manufacturing process was “capable of preventing microbial contamination” of these products, which contain naphazoline hydrochloride (HC1) 0.1%.
For example, the drug was being manufactured in a Grade D clean area, an area without the “appropriate controls to prevent microbial contamination.” The firm also failed to establish and validate a process for making sterile drug products and did not follow appropriate written procedures for sterilizing equipment used to manufacture the product.
The company also distributed batches of the product to the US market without conducting sterility testing or testing for particles and foreign matter prior to release.
Company did not view drugs as sterile
In response, the company told FDA it did not consider these products sterile, so the requirements for producing sterile drug products did not apply.
FDA disagreed, telling the firm that the products, which are applied into the eyes, are considered sterile. “Your interpretation that this drug product is not required to be sterile is incorrect.”
The firm also failed to initiate an investigation when the infrared (IR) spectrum of naphazoline HCl active pharmaceutical ingredient (API) lot “was found to be different from the standard.” Yet this API went into pi yen chin drug batches distributed to the US market.
Further, an investigation into unknown peaks, which were detected during release assay testing for batches, was not performed.
Rust found on equipment
The company was also faulted for using reusable, non-sterile wipes to clean equipment. In addition, rust was found on equipment that was attached to the filling line; the equipment comes into direct contact with the ophthalmic product. A “fraying conveyor belt” was also found on the filling line.
The firm plans to suspend manufacturing of drugs to the US market. FDA requested that it be informed before resuming operations. The firm was placed on an import alert on 4 November 2021.
Warning letter


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Tags: FDA, letter, warning

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