# FDA WARNING_LETTER - Lilly del Caribe, Inc. (PR05) - July 31, 2009

Source: https://www.keypedia.com/records/warning_letter/lilly-del-caribe-inc-pr05/73ce82e4-13c3-4bb8-8dd9-3c1280ffcfa8

> FDA WARNING_LETTER for Lilly del Caribe, Inc. (PR05) on July 31, 2009. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lilly del Caribe, Inc. (PR05)
- Inspection Date: 2009-07-31
- Product Type: Drugs
- Office Name: San Juan District Office
- Summary: This Warning Letter, dated [Date of Letter], addresses Eli Lilly & Company's active pharmaceutical ingredient (API) manufacturing facility, Lilly del Caribe, following a July 08-31, 2009 inspection. The inspection revealed a significant deviation from Current Good Manufacturing Practice (CGMP) requirements for API manufacture, rendering their Lyspro Insulin Zinc Crystals API adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

The primary violation identified was the firm's failure to adequately investigate critical deviations or batch failures. Specifically, investigation TR# (b)(4) determined the disposition of 36 API batches based on an unvalidated test method. This investigation concerned 36 batches of (b)(4) exhibiting (b)(4), a process affecting the API. The investigation found an increase in (b)(4) which can cause (b)(4) affecting API quality. Twenty-four of these batches were released based on results from the unvalidated (b)(4) test, despite knowledge of a similar event at a sister plant. The (b)(4) test, intended as a limit test, was improperly used for final disposition. Subsequent studies in April 2008 showed the (b)(4) test method was not linear, indicating no assurance of the actual percentage of (b)(4) present in affected batches. The firm failed to assess all affected batches released for

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