FDA 483 - Infupharma LLC d.b.a. President Pharmacy - February 05, 2015

During an inspection from February 3-5, 2015, the FDA observed deficiencies at Infupharma LLC d.b.a. President Pharmacy, a producer of non-sterile drugs located at 2013 Harding Street, Hollywood, FL. The inspection was conducted by CDR Ileana Barreto-Pettit and the report was issued to Michel Rizo, President.

Two observations were noted:

1. **Lack of Finished Drug Product Testing:** The firm does not test finished drug products for conformance to final specifications, identity, and strength of active ingredients prior to distribution. For example, for the last three months, non-sterile drug products including progesterone, testosterone, estriol, HCG, and T3/T4 in capsule, cream, or suppository forms were distributed without testing for potency and microbial limit specifications.

2. **Absence of Objectionable Microorganism Testing:** Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, non-sterile preparations are not tested for the presence of objectionable microorganisms prior to distribution.

These observations indicate non-compliance with regulatory requirements for drug product release and microbial testing, as per Section 704(b) of the Federal Food, Drug and Cosmetic Act.