Chinese Firm Used White Out to Change Regulatory Records, FDA Says
Posted 06 December 2012 | By
Chinese over-the-counter (OTC) manufacturer Shanghai Huhui Daily Use Chemical Products Company ('Shanghai Huhui') has been blasted by US Food and Drug Administration (FDA) inspectors for allegedly interfering with an investigation of the facility by using white-out on regulatory documents, among other serious alleged violations.
The alleged deficiencies are outlined in a 14 November 2012 warning letter to Shanghai Huhui, released to the public on 5 December 2012. In the letter, FDA outlines the results of a 6-10 February 2012 regulatory inspection, taking note of a number of current good manufacturing practice (CGMP) violations it said it observed during the course of the inspection.
Many of the violations were not uncommon for FDA warning letters: unavailable component batch testing records, inadequate quality control staff authority, a lack of standardized procedures for testing, inadequate process validation and unapproved marketing statements on products.
By themselves, such violations form a sufficient basis for a warning letter. But FDA explained that its investigators found much more serious violations: contradictory yields indicating that an unexplained mix-up had occurred went unnoticed; potentially falsified records as indicated by activity records indicating both processing and cleaning occurring during the exact same time; products stored in facilities without temperature control and without stability data; products sent to market without first testing samples from the manufactured lot; products that did not meet US Pharmacopoeia monographs which they used to market their products; and a general failure to register the facility with FDA for the three years preceding 2012.
Defiance and White Out
Other violations bordered on outright defiance, said FDA. "[Shanghai Huhui] refused to provide the test records of ... an active pharmaceutical ingredient (API) used to manufacture the drug products," including three skin protectants it manufactures. The company allegedly refused to provide other data regarding other tests, including the testing methods used on raw materials used in the production of certain unspecified products.
"The above examples constitute unreasonable denials in permitting FDA to assess the manufacturing conditions at your facility," FDA explained.
But worst of all may well have been the "presence of opaque correction fluid in many of [Shanghai Huhui's] production records"-white out-used to change lot numbers, signatures, temperature and viscosity readings.
"In each instance, there was no notation of who made the change or when and why the change was made. Please note that batch records are to document accurately the production and control activities associated with each lot," FDA wrote. "A Quality Control Unit (QCU) cannot reasonably rely on records containing unexplained corrections to make batch release decisions."
"The above four examples raise serious concerns regarding the integrity, reliability and traceability of the data generated and documents in your batch product records," FDA added.
FDA did not ban the company's products from entering the country-yet. The agency said it "may withhold approval for any new applications or supplements," and "may" refuse admission to products manufactured at the Shanghai facility. "The articles are subject to refusal of admission… in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning [of US federal law]," wrote concluded.
Similar violations often lead to FDA making a declaration that products will not be allowed into the country if violations are not immediately fixed or regulators given access to documents. A September 2012 inspection of Fercy Personal Care Products of China, for instance, saw FDA regulators physically kicked out of the facility mid-inspection, denying them access to documents. That firm was immediately put on import alert.
(h/t to Pharmalot)