# FDA 483 - Avenue Pharmacy Inc dba Pathway Pharmacy - October 04, 2024

Source: https://www.keypedia.com/records/483/avenue-pharmacy-inc-dba-pathway-pharmacy/c0d27f9e-6dde-4a24-bc6c-d7e2862caf81

> FDA 483 for Avenue Pharmacy Inc dba Pathway Pharmacy on October 04, 2024. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Avenue Pharmacy Inc dba Pathway Pharmacy
- Inspection Date: 2024-10-04
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 documents observations from an inspection, detailing issues with drug product quality and facility cleanliness.

**Observation 1** notes that the firm released drug products with strength, purity, or quality issues. Specifically, a Testosterone 2mg/mL cream lot (06102024) dispensed to a patient showed 85.5% potency. Additionally, five bulk drug substance lots used in finished products dispensed to patients exhibited potency failures: Liothyronine (T3) lot #0612202LI at 77.3%, Levothyroxine (T4) lot #06032024 at 121.8%, Levothyroxine (T4) lot #04172024 at 148.3%, and Liothyronine (T3) lot #08072024 at 84.4%.

**Observation 2** identifies contamination in production and adjacent areas. This includes four AC units in the Hazardous Room with white powder residue and dust, potentially leading to product contamination. An open container of Testosterone Cream (lot #09302024@0) was found adjacent to an AC unit. White powder residue was observed on all surfaces in the Hazardous Room (refrigerator, countertops, Bulk Drug Substance containers). A pharmacy technician was seen placing a soiled gloved finger into finished Testosterone Cream

## Related Documents

- [483 - 2014-09-15](https://www.keypedia.com/records/483/avenue-pharmacy-inc-dba-pathway-pharmacy/cb6d978e-2670-4024-9993-7d7c4a12b4c1)
- [STATE_REFERRAL_LETTER - 2014-08-26](https://www.keypedia.com/records/state_referral_letter/avenue-pharmacy-inc-dba-pathway-pharmacy/a0dda286-abf1-4e41-accc-0e2ddeaed73e)
- [483 - 2021-06-22](https://www.keypedia.com/records/483/avenue-pharmacy-inc-dba-pathway-pharmacy/705227b4-6510-45c7-a6ad-5ec959cf0b1e)

## Related Officers

- [Pharmacy Compounding National Expert at FDA](https://www.keypedia.com/people/jessica-p-mcalister/d892c069-d283-4bb0-9cbb-78e463bfc1ea)

Company: https://www.keypedia.com/companies/avenue-pharmacy-inc-dba-pathway-pharmacy/435161a3-396b-4f18-917c-ced65e1d1e3a

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c