FDA warns Pharmedica over contamination controls for sterile eye drops

The US Food and Drug Administration (FDA) recently issued a warning letter to Pharmedica USA for a multitude of good manufacturing practice (GMP) violations tied to the production of sterile eye drops, including inadequate contamination safeguards and lax process controls. The company has since announced a recall of its eye drops, and has urged consumers to immediately stop using the products, saying they can cause blindness.

The company, based in Phoenix, AZ, made multi-dose presentative-free OTC ophthalmic drug products. The FDA investigator noted that “drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health” causing product adulteration.

For example, the company lacked an ISO 5 classified area for sterile drug product manufacturing. FDA reminded the firm that “if ophthalmic drugs are not sterile, they pose an unacceptable risk to patients including infection and potential for vision loss.”

The firm responded it was not aware that these products were supposed to be made under sterile conditions and acknowledged the facility was “not designed and equipped to handle or manufacture sterile drug products.” The facility was also in a “state of disrepair.”

Investigators said the firm also failed to qualify their equipment and validate manufacturing processes. The company lacked process performance qualification (PPQ) studies and did not have an ongoing process monitoring program to ensure manufacturing processes were in a state of control.

FDA reminded the firm that “process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. “

The company also failed to test incoming components and accepted materials from suppliers without establishing the reliability of suppliers’ test analyses. Specifically, the company failed to obtain or review the suppliers’ certificate of analysis (COA) for its use of methylsulfonylmethane (MSM).

FDA said the firm also lacked a quality unit to oversee supplier qualifications, batch release, complaints, validation, equipment cleaning and adherence to a stability program.

FDA recommended Pharmedica remove its Purely Soothing 15% MSM drops and Purely Soothing MSM nasal sprays from the US market in February, and the company agreed to the recalls in March. The firm has since stopped manufacturing and distributing all drug products.

In a similar event, in February FDA notified consumers to stop using sterile eye drops made in India from Global Pharmaceutical Healthcare because of microbial contamination.

Warning letter

FDA warns Pharmedica over contamination controls for sterile eye drops

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