Regulatory Focus™ > News Articles > In Unusual One-Two Punch, FDA Follows 'Extensive' Warning Letter With Safety Communication

In Unusual One-Two Punch, FDA Follows 'Extensive' Warning Letter With Safety Communication

Posted 30 April 2014 | By Alexander Gaffney, RAC

A Warning Letter to medical device manufacturer Shasta Technologies has highlighted major alleged deficiencies at the company's Sherwood, Ore., manufacturing facility, resulting in an unusual warning about the company's blood glucose testing supplies.

Warning Letter

According to the Warning Letter, inspectors from the US Food and Drug Administration (FDA) found serious problems during a December 2013 inspection of the Sherwood facility.

For example, FDA said when its inspectors asked to see records of corrective and preventive actions (CAPA)-actions taken to correct identified problems and prevent them from happening again-they were not made available. FDA explained that the company's CEO "indicated that Shasta does not have CAPA procedures," and instead relies on contract manufacturers to oversee CAPA.

FDA called this inadequate, noting that Shasta didn't sufficiently oversee the CAPA activities of its contactors.

The company was also chided by FDA for allegedly failing to maintain a system to receive, review or evaluate complaints received by consumers. Again, Shasta said its contract manufacturers were supposed to assume this function, while FDA maintains that the contracting company (Shasta) has ultimate responsibility for all quality functions related to its product.

Further, FDA said it could find "no purchasing control procedures" governing how its contract manufacturers and marketers ensure that its products meet specified requirements.

"Specifically, [Shasta] has indicated that contractors are responsible for document controls, purchasing controls, and CAPA, and that [a contractor] is responsible for handling complaints," FDA wrote. "However, your firm did not provide evidence that it has defined, documented, and implemented purchasing control procedures to describe how it controls services provided by these contractors." The CEO of the company indicated to FDA that Shasta "does not have purchasing control procedures."

Similar allegations fleshed out an extensive Warning Letter to Shasta-failure to maintain document controls, failure to maintain quality requirements, failure to set quality expectations in its management staff, failure to maintain a device master record (DMR), and failure to establish procedures for quality audits.

Can't Contract Out Responsibility

In many-but not all-cases, FDA indicated that Shasta indicated that it felt its responsibilities were borne by its contractors. FDA has previously indicated that it feels quite differently, such as in a series of Warning Letters sent to dietary supplement manufacturers in 2013.

"Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements," FDA wrote, citing the now-famous court decision of United States v. Park. That court case held that criminal wrongdoing may be proven even if a person has delegated their responsibility to others under the theory that agents who are "vested with the responsibility, and power commensurate with that responsibility," to ensure compliance with the law have the obligation to ensure compliance.

Problems With Testing Strips

The latter parts of FDA's Warning Letter to Shasta allege serious problems with its GenStrip Blood Glucose Test Strips, which are labeled for use with LifeScan One Touch Ultra, Ultra2 and UltraMini blood glucose strips.

FDA said that some of the company's products had never received approval from FDA, making them adulterated and misbranded under the Federal Food, Drug and Cosmetic Act (FD&C Act).

FDA also indicated that because Shasta had "failed or refused to furnish material or information respecting the device" required under the FD&C Act and FDA's Medical Device Reporting Regulation (21 CFR 803), the GenStrip Blood Glucose Test Strips would also be declared misbranded.

In a subsequent safety communication released on the same day, FDA indicated that it was advising all patients and healthcare providers to "stop using" the strips because they could report incorrect blood glucose levels. The communication referred to FDA's Warning Letter, characterizing its findings as "extensive."

The immediate warning is an unusually strong move by FDA. Even in cases where FDA has instituted import alerts against pharmaceutical companies for failing to adhere to basic CGMP standards or data integrity regulations, the agency has almost always preferred a more subtle approach.

The very public safety communication could be just one more arrow in the agency's enforcement quiver when dealing with noncompliant companies. Whether the agency begins to use it more frequently could be something to keep a close eye on.


FDA Warning Letter to Shasta

FDA Safety Communication


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