The US Food and Drug Administration (FDA) inspected the facility in June and observed a number of violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.
These included failings in determining the identity and strength of active ingredients prior to release, the failure to establish an adequate quality control unit, and failures to ensure laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.
“Your firm indicated to our investigator that you document finished product analysis on a pad of paper, transcribe the test results onto a certificate of analysis, and then destroy the piece of paper. There is no assurance that the testing was conducted in the first place, and there is no record that any associated calculations were performed,” the letter stated.
The Agency told Kim Chemicals – a firm which makes and exports toiletries and pharmaceutical products – its quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it makes, and thus recommended the firm provide a thorough investigation, risk assessment and management strategy in response to the warning.
The drugmaker was also pulled up on misbranding issues relating to several of its products, including Sofskin Vaporizing Chest Rub, which according to Kim’s label is a nasal decongestant and cough suppressant.
“The labeled active ingredients—menthol, camphor, and eucalyptus oil—are not consistent with the active ingredients for nasal decongestant drug products as described in the cough/cold final monograph.”
The firm has been on Import Alert 66-40 – Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs – since August 21.
The FDA also released details this week of a warning letter sent to Aztex Enterprises following a Jue inspection of the firm’s Burlington, Ontario facility in June.
While the Agency cited Aztex has not established a formal quality unit, nor established written procedures describing responsibilities of the quality unit, it also found the firm had used adulterated materials purchased from a firm on Import Alert 66-40.
Aztex itself was placed on Import Alert 66-40 on October 19.