Warning Letter Analysis: Companies hit for CGMP, Reporting Violations

Posted 17 May 2012 By Alexander Gaffney

The US Food and Drug Administration (FDA) released three warning letters on 17 May 2012 previously issued to companies in the healthcare product sector, including two pharmaceutical manufacturers and one blood products supplier detailing current Good Manufacturing Practices (cGMP) and adverse event reporting violations.


Selder S.A. de C.V. (Pharmaceutical)

A warning letter sent to Selder S.A.'s Director General and Owner, Alejandro Villarreal, by FDA identifies numerous cGMP violations at Selder S.A.'s Mexico-based manufacturing facility. As a result of those violations, FDA has issued a ban on all products manufactured at the facility until it is able to prove compliance with FDA guidelines.

The cGMP violations alleged by FDA include inadequate stability testing procedures, un-established quality management procedures, inadequate process management controls, failure to establish laboratory control records, and failure to document or establish test methods.

FDA noted Selder S.A. had been presented with the opportunity to respond to FDA's warning letter, but had failed to do so within the fifteen day requirement.

The agency also cited Selder S.A. for alleged misbranding violations for marking several products containing acetaminophen without required warning information.

"Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm's compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer," wrote Steven Lynn, acting director of FDA's Office of Manufacturing and Product Quality, Office of Compliance. "In addition, until such time as your manufacturing practices are verified to comply with cGMPs, your firm will remain on FDA Import Alert and FDA will continue to refuse admission of all articles manufactured at" it's Mexico facility.


Acorda Therapeutics Inc. (Pharmaceutical)

FDA's 10 May 2012 warning letter to Acorda Therapeutics Inc. CEO Ron Cohen claims the New York-based facility was deficient in its duties to "submit all adverse drug experiences that are both serious and unexpected to FDA with 15 calendar days."

Further deficiencies are alleged in Acorda's adherence to federal regulations in related areas. For instance, FDA says Acorda failed to "develop adequate written procedures" for handling adverse event reports, failed to maintain adverse drug event records and raw data, and failed to report each adverse drug experience.

FDA chided Acorda for not having written standard operating procedures for reporting adverse events. "Please note, this is a repeat observation from the 19 January 2006 FDA inspection at which time Form FDA 483 "Inspectional Observations" was issued to [Acorda] for failure to have written procedures for reporting postmarketing adverse drug experiences for [Acorda's] products," FDA wrote.

While Acorda responded to FDA's warning letter and its claims, the letter was not received by FDA within the mandatory 15-day timeframe enforced by FDA, and was thus not contained in FDA's summary of the letter's contents.


Innova Health System (Blood Products)

A warning letter sent by FDA to Innova's President and COO Mark Stauder claims government investigators found "numerous significant violations of the cGMP regulations for blood and blood products" at Innova's Falls Church, VA facility.

In particular, Innova was found to be negligent in consistently testing equipment used to test blood units for sexually transmitted diseases, failed to ensure donors were "in good health" before drawing blood samples, failed to conduct regular maintenance on infectious disease equipment, failed to report numerous adverse events to FDA, failed to report two Biological Product Deviation Reports to FDA, failed to establish and maintain written standard operating procedures for blood collection and processing, and failed to maintain performance records.

FDA says it received a written response from Innova detailing its intended efforts to fix the noted deviations from federal regulations, but also says Innova must do more to address the "underlying causes of the deviations."

"Your response did not include sufficient information to enable us to assess whether your firm has effectively implemented its proposed corrective actions or whether those corrective actions will adequately address the underlying causes of the deviations described above," wrote FDA.

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