Multiple Violations at Florida Outsourcing Facility
A 11/17-11/21/14 FDA inspection at OPS International, doing business as Olympia Pharmacy, Orlando, FL, found “serious deficiencies in your practices for producing sterile drug products, which put patients at risk.” A 2/4 Warning Letter from the agency’s Florida District Office says the firm’s products “may be produced in an environment that poses a significant contamination risk.”
The letter notes that Olympia has a history of poor sterile practices and received a 2013 Warning Letter when the firm was under a different name.
The investigator found that the facility failed to meet all the conditions of Section 503B under which it had registered as an outsourcing facility that would allow products to be exempt from drug approval requirements. Because Olympia’s compounded drug products have not met all the Section 503B conditions, they are not eligible for exemption from drug approval and labeling requirements, the letter says.
CGMP violations observed at the facility, according to the letter, included:
failing to ensure adequate systems for maintaining any equipment used to control aseptic conditions; failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile; failing to adequately design the facility with adequate separation or defined areas or such other control systems necessary to prevent contamination or mix-ups; failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas; and failing to have for each batch of drug product appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient before release.
The letter also says that the firm does not have any FDA-approved applications on file for its drug products, has compounded products that are intended for conditions that are not amenable to self-diagnosis and treatment by laypersons and thus have labeling that doesn’t contain adequate directions for their intended use; and failed to submit a report to FDA on initial registration as an outsourcing facility.
The District Office acknowledges the firm’s responses to the inspection observations and says that some proposed corrective actions appear adequate, while others are deficient. The agency strongly recommended that the firm’s management immediately undertake a comprehensive assessment of its operations, including facility design, procedures, personnel, processes, materials, and systems. It says that a third-party consultant with relevant sterile drug manufacturing experience could be useful in conducting such a comprehensive evaluation.
Olympia was told to take prompt action to correct the violations and prevent their recurrence and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.