# FDA WARNING_LETTER - terry yon & associates, inc./ - November 18, 2009

Source: https://www.keypedia.com/records/warning_letter/terry-yon-associates-inc/1970ab7a-b4ee-4a70-9ccf-e17515f0f6ea

> FDA WARNING_LETTER for terry yon & associates, inc./ on November 18, 2009. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: terry yon & associates, inc./
- Inspection Date: 2009-11-18
- Product Type: Devices
- Office Name: Florida District Office
- Summary: On May 12, 2010, the FDA issued a Warning Letter to Terry Yon & Associates, Inc. dba TYA Pharmaceuticals following a November 16-18, 2009 inspection. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's December 7, 2009 response was deemed insufficient.

Key violations included:
1.  **Failure to establish separate or defined manufacturing areas (21 CFR § 211.42(c)(5)) and separate facilities for penicillin operations (21 CFR § 211.42(d)).** The firm repackaged penicillin (e.g., amoxicillin) and non-penicillin beta-lactam (e.g., cephalexin) products in the same hooded cabinet within a single laminar air-flow room. This was a repeat observation from a February 2007 inspection, and the firm's assurance of discontinuing penicillin repackaging was deemed inadequate due to past non-compliance.
2.  **Failure to test non-penicillin drug products for penicillin cross-contamination (21 CFR § 211.176).** Despite

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Company: https://www.keypedia.com/companies/terry-yon-associates-inc/2cba383f-a2b3-4b43-bb74-4f7826197df5

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