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New York ophthalmic drugmaker cited for environmental and data integrity issues

Posted 27 May 2020 | By Kari Oakes 

New York ophthalmic drugmaker cited for environmental and data integrity issues

The US Food and Drug Administration (FDA) has warned a New York based pharmaceutical company for data falsification and failing to establish adequate monitoring in aseptic processing areas.
The firm, Altaire Pharmaceuticals, manufactures sterile ophthalmic drug products, as well as over the counter ophthalmic and homoeopathic products.
In its warning letter dated 12 March 2020, the FDA detailed findings from a 2019 inspection, where inspectors found that the firm failed to open investigations when plates taken from ISO 5 areas had growth that exceeded action limits. “Our inspection revealed serious data integrity breaches and other serious violations relating to environmental and personnel monitoring,” FDA said.
In at least one case cited in the warning letter, an environmental monitoring plate with colonies too numerous to count was recorded as having zero growth. Though post-activity personnel monitoring had lapsed for up to a year, technicians continued to record results of zero growth on report forms.
“Due to this lack of authentic data relating to the microbial control of personnel who perform aseptic processing operations, you lacked information that is basic to determining aseptic processing control period for up to a year, you lacked the ability to identify microbial contamination risks posed by personnel,” FDA noted.
Additionally, Altaire was cited for falsifying laboratory data used in making batch release decisions. Samples observed to be turbid were not tested for sterility, and the firm’s commitment to have outside finished product sterility testing done for completed batches would not necessarily establish the sterility of all finished units, since distribution of contamination is usually non-uniform.
Gowning and gloving procedures were also observed to be inadequate during aseptic operations, where FDA inspectors also observed operators with exposed skin. Media fill batch records were also found inadequate.
Finally, FDA noted that equipment on Altaire’s filling line had aluminum foil and duct tape attached to its hopper.
The FDA asked the firm to provide a comprehensive response with the assistance of a qualified outside consultant to develop a current good manufacturing practice compliant data integrity program. The agency asked for a full investigation including retrospective analysis of data records and reporting, personnel interviews, as well as a risk assessment and management strategy.
FDA noted that after the inspection Altaire ceased operations for some of its drug products and initiated a recall in June 2019.


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