# FDA WARNING_LETTER - Axium Healthcare Pharmacy dba Balanced Solutions Compounding - March 15, 2013

Source: https://www.keypedia.com/records/warning_letter/axium-healthcare-pharmacy-dba-balanced-solutions-compounding/1e095cc6-6fd5-4542-a319-8b57cd87076d

> FDA WARNING_LETTER for Axium Healthcare Pharmacy dba Balanced Solutions Compounding on March 15, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Inspection Date: 2013-03-15
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: On July 16, 2013, the FDA issued a Warning Letter to Axium Healthcare Pharmacy, Inc. dba Balanced Solutions Compounding Pharmacy, following an inspection from March 12-15, 2013. The inspection revealed the firm was producing a significant number of drug products without valid prescriptions for individually-identified patients, and observed serious deficiencies in sterile drug product manufacturing practices, leading to two contaminated product recalls.

Violations included microbial contamination in Chromium Chloride Injection and black particles in Triamcinolone Acetonide. The firm's aseptic processing area lacked a unidirectional flow hood, using an inadequate HEPA filter. Technicians wore non-sterile gowns, exposed bare skin, extended arms over sterile vials, and moved improperly in aseptic areas.

These issues mean the drugs do not qualify for exemptions under FDCA section 503A or FDA's Compliance Policy Guide 460.200. Consequently, drugs produced without individual prescriptions are unapproved new drugs (violating sections 505(a) and 502(f)(1) of the FDCA) and misbranded. Sterile products are adulterated under section 501(a)(2)(A) due to insanitary conditions. Furthermore, the firm is subject to CGMP regulations (21 CFR Parts 210 and 211), with observed violations including failure to reject non-conforming products, inadequate

## Related Documents

- [483 - 2013-03-15](https://www.keypedia.com/records/483/axium-healthcare-pharmacy-dba-balanced-solutions-compounding/5cfa0200-ead8-45c8-a30f-2a79213628e4)

## Related Officers

- [David B. Dillion](https://www.keypedia.com/people/david-b-dillion/7e925051-e64a-4e24-bbdc-ce84d6e7ecbb)
- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

Company: https://www.keypedia.com/companies/axium-healthcare-pharmacy-dba-balanced-solutions-compounding/443fee7a-b5a4-49ad-97e4-b846df9d31db

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