Warning Letters Week Of 9/27/2020: Aseptic Process Issues

Last week, FDA issued one Warning Letter to a drug manufacturer and five to compounding pharmacies. The drug manufacturer Warning Letter focused on aseptic processing deficiencies.

Interestingly, two of the Warning Letters issued to compounding pharmacies were based on inspections conducted in 2018.

Drug Warning and Untitled Letters

Panacea Biotec Limited

Panacea Biotec Limited (New Delhi, India) received a Warning Letter on September 24, 2020, based on the outcome of an inspection ending February 20, 2020. The warning letter identifies two multipart deficiencies in the aseptic processing of drug products. These deficiencies include but are not limited to:

• Failure to have adequate laboratory controls shown by a lack of data on microorganisms’ identification from the aseptic processing areas. Only one of 6,360 microorganisms isolated from the ISO 7 area was identified. Identification was attempted using an “incomplete and crude photographic library.” Basic microbiological data were not retained. The firm’s response was inadequate because they did not commit to implementing a microbial identification program for ancillary cleanrooms. Further, an analyst failed to follow all steps in the governing endotoxin analysis method including vortexing of samples and timing of steps using a calibrated timer. 
• The firm does not adequately monitor the conditions of the aseptic processing facility. The firm lacks an effective system to ensure control of differential pressures; pressure reversals are permitted while deviations “may be” initiated for excursions. FDA concluded that the firm does not have adequate ongoing control over HVAC systems. The limit for 0.5-micron particles was exceeded, yet no investigation was conducted.

Device Warning and Untitled Letters

There were none this week.

BIMO, GCP and GLP Warning and Untitled Letters

There were none this week.

Compounding Pharmacy / Outsourcing Facilities

• Front Door Pharmacy, LLC dba Pure Pharmacy (Houston, TX) received a Warning Letter on July 1, 2020, based on the outcome of an inspection ending March 18, 2019. 
• Accurate RX Pharmacy Consulting LLC dba Accurate Rx Pharmacy  (Columbia, MO) received a Warning Letter on September 2, 2020, based on the outcome of an inspection ending September 19, 2018, (yes, two years ago).
• Foothills Professional Pharmacy, LTD (Phoenix, AZ) received a Warning Letter on September 9, 2020, based on the outcome of an inspection ending October 24, 2018. Another one that’s from two years ago.  
• Intrathecal Compounding Specialist, LLC (Scott, LA) received a Warning Letter on September 15, 2020, based on the outcome of an inspection ending February 14, 2019. 
• Randol Mill Pharmacy (Arlington, TX) received a Warning Letter on September 17, 2020, based on the outcome of an inspection ending August 6, 2019.