FDA Warning Letters: 11/22/2020 & 12/1/2020

The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter enforcement with one GMP letter issued to a drug manufacturer and one untitled letter. The following week saw FDA post a Warning Letter issued to a compounding pharmacy.

Drug Warning and Untitled Letters

AUROLIFE PHARMA, LLC

Aurolife Pharma, LLC, with corporate headquarters located in Telangana, India, received a Warning Letter based on two inspections of sites in New Jersey ending February 12, 2020. [Note: Please sign in to your Redica Systems account to access the link. Don’t have a subscription? No problem! Get started for free here.] The firm is part of the Aurobindo group of companies; Aurobindo received a Warning Letter for a site in India in June 2019.

This most recent form 483 was 19 pages long and included 9 observations. FDA recommends that the firm hire a qualified consultant(s) to assist them in coming into GMP compliance. The deficiencies identified in the inspections include, but are not limited to:

• The firm invalidated out-of-specification (OOS) events without sufficient investigation and without identifying a root cause. The OOS result was confirmed by testing the original sample, but a new sample gave a passing result and only the passing result was reported. The failing attribute was one for impurity. The results for five lots of API were invalidated. FDA notes that they did not perform a retrospective analysis of invalidated results to ensure there was adequate scientific evidence to do so.
• The facility is not maintained in a good state of repair. For example, investigators observed water leaks from the ceiling into the encapsulation room. In addition, there were at least five examples of water leaks in the packaging area. The company committed to recalling batches listed in observation #1 of the form 483.
• Cleaning and maintenance of equipment were inadequate because surfaces were observed to be covered in powder throughout the facility. The FDA expressed concern that the widespread visible powder seen in the facility could lead to cross-contamination, and emphasized that this is important because the firm manufactures high potency drug products. The FDA objected to the firm’s response to this observation because they did not address the root cause of the inadequate control of powders in the facility, nor did they propose corrective actions.
• The firm failed to establish adequate process validation evidenced by the PPQ run failures after a process change. Some of the PPQ lots were released without justification after others were rejected for uniformity failures. Eight months after the initial evaluation, the firm reverted to the old manufacturing process. The firm recalled PPQ batches made using the “new” process.

Device Warning and Untitled Letters

There were none this week.

BIMO, GCP and GLP Warning and Untitled Letters

AZURITY PHARMACEUTICALS

Azurity Pharmaceuticals (Wilmington, MA) received an untitled letter from OPDP based on an email sent to healthcare professionals regarding a methotrexate oral solution used in the oncology setting.

Compounding Pharmacy/Outsourcing Facilities

WEST COAST NUCLEAR PHARMACY

West Coast Nuclear Pharmacy (Tampa, FL) received a Warning Letter on October 6, 2020, based on the outcome of an inspection ending March 23, 2018. The Warning Letter includes four adulteration deficiencies, all citing the Food, Drug, and Cosmetic Act.