Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Newton Laboratories, Conyers, GA (4/23): FDA inspected the firm 3/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. It also failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport to possess.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/newton-laboratories-inc-dba-newton-homeopathics-559612-04232019

Surgisil, Plano, TX (4/15): FDA inspected the firm 9/2018 and determined that its Perma Facial Implant is adulterated because it is marketed for augmentation of the lips, which constitutes a major and unapproved change/modification to its intended use. Additionally, a review of the firm’s Web site revealed that promotional materials contain statements that are misleading because they create an impression of official approval of a device instead of clearance of a premarket notification submission.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/surgisil-llp-567886-04152019