FDA Issues Warning Letter to Syntec Pharma Corp

Syntec receives warning letter where FDA finds deviations from CGMP for APIs.

FDA issued a warning letter to Syntec Pharma Corp., located at 96 Gazza Boulevard, Farmingdale, New York 11735, dated July 6, 2021. The warning letter summarized deviations from current good manufacturing practice (CGMP) for APIs.

FDA found that Syntec’s methods, facilities, or controls for manufacturing, processing, packing, or holding didn’t conform to CGMP, and their APIs were adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

On October 7–28, 2020, FDA inspected the company’s drug manufacturing facility. The deviations observed by the investigators were as follows.

According to FDA’s warning letter, Syntec failed to have adequate controls to prevent cross-contamination between API, including receipt, storage, weighing, repackaging, and relabeling of API in the same room using non-dedicated equipment and without appropriate procedures.

During FDA’s inspection, the company stated they didn’t repackage any highly potent API. However, FDA found the company repacked a lot of lomustine. The company also acknowledged inappropriate storing of lomustine and human chorionic gonadotrophin, which were stored at room temperature instead of refrigeration as required by the manufacturers’ certificates of analysis to prevent degradation.

FDA found that Syntec kept weed killer, engine antifreeze coolant, and dry wall repair products in the same room where API and packaging components were stored. The inspectors also found comingled personal food items and unidentified products in unlabeled aluminum bags in the refrigerator where API and chemicals were stored.

Syntec’s response measures to these findings—to divide the pharmaceutical storage area into four sections by using a separate shelf for each of the following categories: cytotoxic compounds, beta-lactam, other potent compounds, and other API—were determined inadequate by FDA.

In addition,FDA stated Syntec failed to establish adequate written procedures for cleaning non-dedicated production equipment used for the API. The company also didn’t document the usage and cleaning of repackaging equipment. For example, Syntec didn’t document equipment used or whether cleaning was performed after repackaging lomustine (lot (b)(4)) on/around April 9, 2020.

According to FDA’s investigation, the company also lacked adequate quality unit (QU) oversight for the manufacture of their APIs. For example, the QU failed to:

  • Perform adequate testing and approve the results for the API prior to release and distribution,
  • Have stability data to support retest or expiration dates, as well as storage conditions, of API when repackaging them into different container-closure systems from their original ones,
  • Establish specifications for the API received, and more.

FDA also reviewed the company’s list of suppliers, and the drug products from three of their API suppliers were subject to an import alert at the time they imported drugs from these firms. Two of these suppliers had been issued warning letters by FDA, explaining issues related to CGMP compliance that caused the drugs to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).

FDA instructed Syntec to correct any deviations promptly.

“Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved deviations may also prevent other Federal agencies from awarding contracts,” FDA stated in the letter.

Source: FDA