FDA Sends Warning Letter to Syntec Pharma Corp
Syntec receives warning letter when FDA finds deviations from CGMP for APIs.
The FDA sent a warning letter to Syntec Pharma Corp., located at 96 Gazza Boulevard, Farmingdale, New York 11735, dated July 6, 2021. The warning letter summarized the deviations from good manufacturing practices (CGMP ) current for APIs.
The FDA found that Syntec’s methods, facilities or controls for manufacturing, processing, packaging or preservation did not comply with 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 USC 351 (a) (2) (B).
From October 7 to 28, 2020, the FDA inspected the company’s drug manufacturing plant. The differences observed by the investigators are as follows.
According to the FDA warning letter, Syntec did not have adequate controls in place to prevent cross-contamination between APIs, including receipt, storage, weighing, repackaging and relabeling of the API in the same room using non-dedicated equipment and without proper procedures.
During the FDA inspection, the company said it had not repackaged any very powerful APIs. However, the FDA found that the company repackages a lot of lomustine. The company also acknowledged the improper storage of lomustine and human chorionic gonadotropin, which were stored at room temperature instead of refrigerated, as required by manufacturers’ certificates of analysis to prevent degradation.
The FDA found that Syntec kept weedkiller, anti-freeze engine coolant, and drywall repair products in the same room where the API and packaging components were stored. Inspectors also found mixed personal foods and unidentified products in unlabeled foil bags in the refrigerator where the API and chemicals were stored.
Syntec’s response measures to these results – dividing the pharmaceutical storage area into four sections using a separate shelf for each of the following categories: cytotoxic compounds, beta-lactams, other potent compounds and other APIs – were deemed inadequate by the FDA.
Additionally, the FDA said Syntec did not have adequate written procedures in place for cleaning non-dedicated production equipment used for API. The company also did not document the use and cleaning of the reconditioning equipment. For example, Syntec did not document the material used or whether the cleaning was carried out after the reconditioning of lomustine (lot (b) (4)) on / around April 9, 2020.
According to the FDA investigation, the company also lacked adequate quality unit (QU) monitoring for the manufacture of its APIs. For example, the QU failed to:
- Perform adequate testing and approve API results before release and distribution,
- Have stability data to support retest or expiration dates, as well as storage conditions, of APIs when they are repackaged in container closure systems different from their original systems,
- Establish specifications for the received API, and more.
The FDA also reviewed the company’s list of suppliers, and pharmaceuticals from three of their API suppliers were subject to import alert when they imported drugs from those companies. Two of these suppliers had received warning letters from the FDA, explaining the CGMP compliance issues that caused the drugs to be adulterated under section 501 (a) (2) (B) of the FD&C Act, 21 USC 351 (a) (2) (B).
The FDA has asked Syntec to promptly correct any discrepancies.
“Failure to address this matter promptly and adequately may result in regulatory or judicial action without further notice, including, without limitation, attachment and injunction. Unresolved discrepancies can also prevent other federal agencies from awarding contracts, ”the FDA said in the letter.