FDA WARNING_LETTER - Shamrock Medical Solutions Group LLC - August 24, 2011

During an August 3-24, 2011 inspection, the FDA identified significant Current Good Manufacturing Practice (CGMP) violations at Shamrock Medical Solutions Group, LLC's pharmaceutical manufacturing facility in Lewis Center, Ohio. These violations caused drug products to be adulterated and misbranded, violating sections 501(a)(2)(B), 502(b)(2), and 301(a) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Computer System Controls (21 CFR § 211.68(b)):** Repackaging technicians changed master labels, leading to mislabeled products (e.g., Levothyroxine Sodium 150 mcg labeled as 150 mg, Metoclopramide misspelled as Metroclopramide). Proposed software revisions to restrict access were not implemented, and the Quality Assurance Unit (QAU) failed to adequately review master production records as per SOP S-0002.00-PROD. 2. **Lack of Adequate Production and Process Controls (21 CFR § 211.100(a)):** No written procedures existed for manual repackaging of liquid drugs into oral syringes or fluid dose cups, resulting in customer complaints of air bubbles and low fill volumes for products like oxycodone and morphine sulfate oral solutions. 3. **Failure to Follow