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More Out-of-Compliance Sterile Drug Compounders

A warning letter and two alerts issued during July show FDA’s continuing crackdown on sterile practices at drug compounders, including inadequate sterility procedures, environmental monitoring and gowning (IPQ April 14, 2014). The warning letter was issued to Dallas-based Abrams Royal Pharmacy following an inspection in December. FDA also alerted healthcare professionals during July to avoid […]

Data Integrity Concerns at Italian API Manufacturer

Trifarma’s API plant in Rozzano, Italy drew a warning letter in July that included data integrity concerns related to maintaining complete data and unauthorized access. Training of employees was also a concern. The letter addressed the findings at a January inspection. [For more on FDA’s recent findings regarding data integrity, see IPQ April 28, 2014.]

Injunction Against Laclede For Sale of Unapproved Drugs

An injunction was filed in late June against California-based Laclede for distributing unapproved/misbranded drugs.

GMP Warning Letters Continue to Compounding Pharmacies

In June, two more compounding pharmacies received warning letters from FDA – Sunnymede Pharmacy, doing business as Lee and Company and Lee Pharmacy, and Pharmacy Creations. Both letters include citations involving contamination SOPs and environmental monitoring – the most common problems FDA is finding at sterile compounding facilities (IPQ April 14, 2014).

Aurobindo Notifies FDA on 86 ANDA Withdrawals

In mid-June, FDA announced the withdrawal of 86 Aurobindo ANDAs, following the firm’s notification to the agency that it was no longer marketing them and its request for the withdrawals.

Two Foreign API Manufacturers Issued Warning Letters

In June, Apotex and Tianjin Zhongan Pharmaceutical received warning letters addressing API manufacturing issues. Apotex was cited in its letter for data integrity issues at its facility in Bangalore, India, based on inspection findings in late January. The inspection findings resulted in an import alert being placed on products from the facility in April (IPQ […]

EMA Removes Ranbaxy API Plant from Ban

In early June, EMA announced that a reinspection of Ranbaxy’s Toansa, India API plant revealed a number of GMP deficiencies, but no risk to public health, and that the import ban placed on it was being removed. The FDA import alert remains in place after the agency’s follow-up inspection of the plant in January (IPQ […]

U.S. Wockhardt Plant Receives 483 on Data Handling

In late March, FDA issued a 483 to a Wockhardt facility in Morgan Grove, Illinois for lab data handling issues similar to those found at the firm’s facilities in India (IPQ April 28, 2014). Of primary concern in the 483, as at the Indian facilities, is the use of “trial” testing and the lack of […]

Sterile Compounding Warning Letters Continue

FDA’s warning letter stream to sterile drug product compounding pharmacies continued in April and May with letters to: Blue Ridge Pharmacy and Compounding Center, Grandpa’s Compounding Pharmacy, Brookfield Prescription Center, and Nature’s Pharmacy & Compounding Center. Drug approval and sanitization issues remain top concerns [See IPQ April 14, 2014 for an update on FDA’s crackdown […]

UK MHRA’s Compliance Management Upgrade Includes “Risk Intelligence IT System” for Drug Inspection Targeting

U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) is creating a comprehensive “Risk Intelligence IT System” for determining where to deploy its inspection resources that captures and analyzes a wide variety of inputs from industry, public, and agency information sources....
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