FDA warns Indian API supplier or data integrity lapses, Chinese contract lab for inadequate testing

The US Food and Drug Administration (FDA) has warned an active pharmaceutical ingredient (API) maker in India for falsifying manufacturing records and issued a warning letter to a contract testing lab in China for its lax testing approach.

Other recent warning letters targeted two Chinese OTC drugmakers for inadequate screening of incoming components.

Global Calcium chastised for data integrity failings

Global Calcium, an API supplier, was targeted in a 16 January warning letter for misrepresenting its production records for certain APIs at its Tamil Nadu, India facility during an inspection last summer. According to the company’s website, it makes 150 products, including specialty APIs, ophthalmic APIs, and oncology APIs, and has 14 manufacturing plants that distribute products globally.

First, FDA said the firm failed to account for how it could make two different APIs at the same time on the same piece of equipment. “For example, your batch records and equipment logbooks show the same equipment including, but not limited to [redacted] were used at the same time to manufacture [redacted] USP and [redacted] USP.”

Investigators also found that the firm deleted multiple electronic records during the inspection. Investigators said that certain Microsoft Excel documents were found on a desktop computer one day but would be deleted the next day. These files included cleaning validation records and production reports. FDA stated that “without access to the files, the investigators were unable to determine their purpose and adequately evaluate your adherence to CGMP.”

Company officials stated that the production head directed the creation of falsified manufacturing records to misrepresent activities related to API production, allowing the plant to claim production incentives.

The firm also claimed that Microsoft Excel files were deleted to “avoid unwanted conversation” with the investigators.

FDA also noted that the facility was not in an “acceptable state of repair.”

In one room, there was liquid pooled in the floor cavity around the exit pipe. Additionally, a similar liquid was dripping from a junction of the ceiling pipes in the area below this room. "The liquid was dripping onto processing equipment that was labeled as clean and ready for use."

FDA placed products from the firm on Import Alert on 20 December 2024, and the agency has directed it contact FDA within five days of receiving the letter.

GMP violations found at Chinese contract testing lab

FDA also issued a warning letter to Center for Instrumental Analysis of China Pharmaceutical University in Nanjing City, China on 23 January for its flawed testing program for APIs. The firm is a contract testing lab which analyzes APIs and intermediates through use of Nuclear Magnetic Resonance spectroscopy (NMR).

The violations included a failure to ensure that laboratory testing records were complete. For example, its test record of samples contained only two lines of numbers with no explanation headers or titles. Further, the testing records did not document sample preparation, the test procedure used, or system suitability.

Additionally, the testing records were not reviewed by a second person prior to sharing results with customers.

The company was also taken to task for failing to provide laboratory records in a timely manner. When investigators requested these records, company officials said it would be “difficult to locate the data because there were many archived hard drives and only the archiving personnel could retrieve the data.”

FDA also said the company lacked proper control over its computer systems. The NMR equipment was also utilized for academic teaching and research, and it seems that multiple users shared a single login ID.

The company said it has stopped all testing services for APIs destined for the US market.

Two Chinese companies targeted for inadequate testing of ingredients

FDA also warned two companies in China for inadequate testing of ingredients used in OTC products.

In a warning letter to Shantou Kangjie Daily Chemical Industry, based in Guangdong, China, FDA said the firm did not conduct adequate identity testing on incoming ingredients used to make hand sanitizers.

“In response to our request, you stated that you do not perform identity testing on each shipment of each lot of drug ingredients (components) before they are released for use in manufacturing,” FDA said.

FDA also sent a warning letter to Imperial Palace Commodity in Dongguan, China. The company makes OTC products, including alcohol wipes. Through a review of its records submitted in response to a March 2024 request for records, FDA said the company failed to test incoming components, such as glycerin components at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination, and test ethanol for methanol contamination, which has also resulted in various lethal poisonings worldwide. Instead, the firm relied on the certificates of analysis (COAs) from their suppliers without further testing.

FDA placed products from both firms on Import Alert in January.

Global Calcium, Center for Instrumental Analysis, Shantou Kangjie Daily Chemical, Imperial Palace

FDA warns Indian API supplier or data integrity lapses, Chinese contract lab for inadequate testing

Related topics

Recommended content

Welcome to the new RAPS Digital Experience