Enforcement was light on warning letters this week: one to a device manufacturer, one to a compounding pharmacy and one to a homeopathic drug manufacturer.
DEVICE | Surgisil, LLP
Surgisil, LLP (Plano, TX) received a warning letter on April 15, 2019 based on the outcome of an inspection ending September 25, 2018. The firm manufactures the Perma Facial Implant. The device is adulterated because the firm did not have an approved premarket approval (PMA) or an approved IDE. Although the firm has a cleared 510(k) for cosmetic augmentation and correction in the face, the inspection determined that the firm’s instructional videos were marketing the device for use in lip augmentation which is deemed to be a major change for which the firm did not have approval.
DRUGS, HOMEOPATHIC | Newton Laboratories Inc DBA Newton Homeopathics
Newton Laboratories Inc DBA Newton Homeopathics (Conyers, GA) received a warning letter on April 23, 2019 based on the outcome of an inspection ending March 30, 2019. The firm’s drugs are adulterated, misbranded and also the firm distributes unapproved new animal drugs. Several of the deficiencies were repeats from inspections as far back as 2006 and 2008. FDA suggests they hire a consultant to assist them in coming into GMP compliance. The deficiencies include but are not limited to:
- The firm failed to investigate microbial results from their contract laboratory that were outside of limits both for water and finished product.
- Manufacturing processes have not been validated. Further some are manufactured from ingredients that pose potentially toxic side effects. FDA identifies this as a repeat observation from 2012 and 2017.
- The firm did not validate cleaning of multi-use equipment and frequently had failing microbial and TOC results. Further, they lack a process for ongoing monitoring of manufacturing processes.
- Annual product reviews were not conducted for several products, which is a repeat and “persistent” observation from inspections of 2006 and 2008.
COMPOUNDING PHARMACY | ABC Compounding Co., Inc
ABC Compounding Co., Inc (Morrow, GA) received a warning letter dated April 18, 2019 based on the firm’s listing information, NDC 62257-275.
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About the Author
Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence. She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.
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