# FDA 483 - DNA Pharmacy Services Inc dba Palm Beach Compounding - August 13, 2014

Source: https://www.keypedia.com/records/483/dna-pharmacy-services-inc-dba-palm-beach-compounding/4fffaa2c-9630-423e-9039-e92ab6addf99

> FDA 483 for DNA Pharmacy Services Inc dba Palm Beach Compounding on August 13, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DNA Pharmacy Services Inc dba Palm Beach Compounding
- Inspection Date: 2014-08-13
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: This FDA Form 483 was issued to DNA Pharmacy Services Inc dba Palm Beach Compounding, a producer of non-sterile drugs located in Jupiter, FL, following an inspection from August 11-13, 2014. The inspection identified three observations.

Observation 1 notes the absence of a written testing program for assessing drug product stability. Specifically, there is no data to justify a 9-month beyond-use date (BUD) for Testosterone Cypionate Injection 220mg/mL Lot 03/02/2014:1106, produced on March 2, 2014, and distributed with a BUD of December 27, 2014. The firm's generated stability data only supports a 3-month BUD for this product.

Observation 2 states that each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested for conformance. Specifically, Testosterone Cypionate Injection 220mg/mL Lot 03/02/2014:1106, distributed with a 9-month BUD, lacks current sterility and endotoxin testing data to demonstrate its safety, effectiveness, and stability for that duration.

Observation 3 concerns equipment and utensil maintenance. White residue and scratches were observed inside a component of a high-torque blender used for blending inactive pharmaceutical ingredients before encapsulation. Additionally, materials

## Related Documents

- [483 - 2017-05-23](https://www.keypedia.com/records/483/dna-pharmacy-services-inc-dba-palm-beach-compounding/2b80c841-f7b0-4855-ae86-fb0571fd97d5)

## Related Officers

- [Justine C. Tomasso](https://www.keypedia.com/people/justine-c-tomasso/8a0f6e96-ae0f-47d3-a992-cff9f676e807)

Company: https://www.keypedia.com/companies/dna-pharmacy-services-inc-dba-palm-beach-compounding/aa796b43-f6c0-4dd5-bb3a-0cd6ba2e5019

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