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

Source: https://www.keypedia.com/records/483/infupharma-llc-dba-president-pharmacy/662a5816-f07f-4d3e-aacd-48810de84e02

> FDA 483 for Infupharma LLC d.b.a. President Pharmacy on February 05, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Infupharma LLC d.b.a. President Pharmacy
- Inspection Date: 2015-02-05
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: 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.

## Related Documents

- [483_RESPONSE - 2011-10-12](https://www.keypedia.com/records/483_response/infupharma-llc-dba-president-pharmacy/17705e61-13fe-4261-9ce2-b5aa29a24a4e)
- [145 - 2018-05-22](https://www.keypedia.com/records/145/infupharma-llc-dba-president-pharmacy/aaefb0f2-60b3-421d-b2e6-b00ce35a8c66)

## Related Officers

- [Vice President, Technical](https://www.keypedia.com/people/leana-barreto-pettit/51dfd8a1-88d7-4d73-b3d4-85d33bcdf923)
- [Vice President](https://www.keypedia.com/people/ana-barreto/80e66e1c-9875-460a-9648-985607666921)
- [Ileana Barreto-Petit](https://www.keypedia.com/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

Company: https://www.keypedia.com/companies/infupharma-llc-dba-president-pharmacy/61154a75-ec2b-4e25-a5cd-27d8a1ad020f

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9