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KRS Global Blog

Enforcement Updates – Pharmaceutical & Medical Device Regulatory Update, Issue 11

Recent Product Recalls

FDA announced two voluntary, company-initiated recalls. The first recall was from a compounding pharmacy recalling all nonexpired sterile drug preparations due to FDA’s concerns about the lack of sterility associated with the company’s compounding processes. The second recall, initiated by a medical packaging company, involved a recall of certain hospital dose units of ibuprofen tablets due to the mislabeling of some blistered doses.
Click here for a complete listing of FDA Recalls.

Recent Warning Letters

Since the last Update, FDA cited only one medical device manufacturer for violating Quality System Regulation requirements. The infractions in the warning letter included other violations, such as failure to establish procedures for corrective and preventative action and medical device reporting requirements. The firm was also cited for not obtaining premarket approval, 510(k) clearance, or an investigational device exemption for its device prior to marketing. 
FDA continues to aggressively cite compounding pharmacies. FDA warned four compounding pharmacies for multiple violations and noted that the pharmacies were each deficient in their practices for producing sterile drug products. Three of the four compounding pharmacies were also cited for failing to obtain valid prescriptions for their compounding products. 
FDA has seen an increase in Warning Letters to foreign drug manufacturers on data integrity issues, according to a CDERdirector in a July 14, 2014, presentation. In fiscal year 2013, CDER issued eight such letters due to data integrity. As of July 14, 2014, CDER has seen a 50 percent increase to 12 letters. In contrast, international Warning Letters on chain supply issues have dropped significantly from 2013. Issues of Agency concern include not recording activities contemporaneously, backdating, fabricating data, copying existing data as new data, re-running samples, and discarding data.
Click here for FDA’s Warning Letters Home page (scroll down for listing of recently posted Warning Letters).
The Office of Prescription Drug Promotion (“OPDP”) issued one letter to a company after reviewing the company’s professional telephone script for a prescription drug. OPDP determined the script was false and misleading because it omitted important risk information associated with the use of the drug and omitted material facts, rendering the drug misbranded within the meaning of the FDCA.
Click here for a complete listing of 2014 OPDP Warning Letters
http://www.mondaq.com/unitedstates/x/332880/food+drugs+law/Enforcement+Updates+Pharmaceutical+Medical+Device+Regulatory+Update+Issue+11