FDA WARNING_LETTER - Bella Pharmaceuticals, Inc. - July 18, 2017

This FDA Warning Letter, dated February 11, 2019, addresses Bella Pharmaceuticals, Inc., an outsourcing facility that was registered under section 503B of the FDCA from February 23, 2017, until the letter's date. An FDA inspection from June 10 to July 18, 2017, revealed serious deficiencies in sterile drug production, putting patients at risk.

Violations include: 1. **Failure to meet 503B conditions:** Compounding with Fluorescein Sodium, which is not on the 503B bulks list or drug shortage list; inadequate labeling (missing "This is a compounded drug," "Not for Resale," "Office use only," phone number, dosage form, compounding date, storage instructions, ingredient list, adverse event reporting info, and route of administration); and failure to submit required drug product reports upon initial registration (February 2017) and in June 2017. These failures render the products ineligible for 503B exemptions, making them unapproved new drugs and misbranded. 2. **Adulterated drug products (501(a)(2)(A) & 501(a)(2)(B) FDCA):** Sterile drugs were prepared under insanitary conditions. CGMP violations included lack of established procedures to prevent objectionable microorganisms (21 CFR 21