Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
Sept. 15 — In separate warning letters posted online Sept. 15, the FDA told Jaychem Industries Ltd. and Pan Drugs Ltd. that the agency's inspections revealed they hadn't complied with current good manufacturing practices (cGMPs).
The Food and Drug Administration said that as a result of the inspections, drug products made by the companies were considered “adulterated” under the Federal Food, Drug, and Cosmetic Act.
In a letter to Jaychem dated Sept. 4, the FDA said it found violations at an Auckland, New Zealand, facility during an inspection that ended July 10, 2014.
The FDA said Jaychem failed to ensure the quality of components, including active pharmaceutical ingredients from various suppliers. The agency also said the firm failed to establish written control procedures and failed to test finished drug batches for the identity and strength of active ingredients.
Additionally, the FDA said that Jaychem has no data to demonstrate that the chemical and physical properties of a certain product (name of the product was redacted) remain acceptable throughout its shelf life.
In a letter to Pan Drugs dated Sept. 2, the FDA said it found violations at its Vadodara, India, facility during an inspection that ended July 18, 2014.
The FDA said the company failed to properly maintain, repair and keep clean buildings used in the manufacture of active pharmaceutical ingredients (APIs) in a manner that prevents contamination. For example, the agency said its investigator observed holes in the walls and roof, which allowed pigeons access near production equipment in multiple manufacturing areas.
The agency also said Pan Drugs failed to properly maintain equipment used in the manufacture of APIs. The letter said the FDA investigator observed rust, dirt, lubrication leaks and exposed insulation material on and around open drug manufacturing equipment.
In addition, the company failed to maintain complete data derived from all testing and to ensure conformance with established specifications and standards.
The FDA told both companies that they should hire a third-party consultant with appropriate cGMP expertise to comprehensively assess the facilities.
The agency also told both companies that until they complete all corrections, the FDA may withhold approval of any new applications or supplements listing the companies as drug product manufacturers.
The FDA told Pan Drugs that until it receives adequate confirmation that the company has made global corrections, it will not schedule a follow-up inspection and the company will remain on an import alert, meaning that any drug products manufactured by the facility would be refused admission into the U.S.
Both companies were asked to provide a response to the warning letters. The letters were signed by Thomas J. Cosgrove, director of the FDA's Office of Manufacturing Quality.
The letter to Jaychem is at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm462371.htm and the letter to Pan Drugs is at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm462075.htm.
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