# FDA WARNING_LETTER - Martin Avenue Pharmacy, Inc. - July 21, 2014

Source: https://www.keypedia.com/records/warning_letter/martin-avenue-pharmacy-inc/99745005-2f0f-4232-accf-cdd1a211335f

> FDA WARNING_LETTER for Martin Avenue Pharmacy, Inc. on July 21, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Martin Avenue Pharmacy, Inc.
- Inspection Date: 2014-07-21
- Product Type: Drugs
- Office Name: Chicago District Office
- Summary: The FDA issued a Warning Letter to Martin Avenue Pharmacy following a June-July 2014 inspection, identifying significant violations. The pharmacy was found to be producing drug products without valid patient-specific prescriptions and compounding domperidone, which lacks an applicable USP/NF monograph, FDA approval, or inclusion on a Secretary's list under FDCA section 503A(b)(1)(A)(i)(III).

Serious deficiencies in sterile drug production were observed, including using non-sterile materials for cleaning, not using sporicidal agents, inadequate environmental monitoring, poor aseptic technique by operators (touching container interiors with non-sterile gloves, using contaminated vial holders), and failure to demonstrate adequate protection of ISO 5 areas. These issues render products adulterated under FDCA section 501(a)(2)(A).

The firm's compounded drugs without valid prescriptions and domperidone products are deemed unapproved new drugs (violating FDCA sections 505(a) and 301(d)) and misbranded (violating FDCA sections 502(f)(1) and 301(a)). Furthermore, the manufacture of drugs without valid prescriptions subjects the firm to CGMP regulations (21 CFR Parts 210 and 211), with numerous violations cited, including inadequate procedures for preventing microbiological contamination, environmental monitoring, cleaning/disinfection, equipment maintenance, container processing, facility design,

## Related Documents

- [483 - 2014-07-21](https://www.keypedia.com/records/483/martin-avenue-pharmacy-inc/1e962ddc-a8a3-4c78-aab3-d87f249d0cca)

## Related Officers

- [District Director at FDA](https://www.keypedia.com/people/steven-barber/e766c0f7-0002-400f-b83a-a0a6efbf259c)

Company: https://www.keypedia.com/companies/martin-avenue-pharmacy-inc/12cf2ec4-4c8a-4be0-ab37-b1fee27ebddd

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669