# FDA WARNING_LETTER - Columbia Presbyterian Medical Center - June 19, 2008

Source: https://www.keypedia.com/records/warning_letter/columbia-presbyterian-medical-center/b5030d19-8dfd-45d0-8425-977bfef73b58

> FDA WARNING_LETTER for Columbia Presbyterian Medical Center on June 19, 2008. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Columbia Presbyterian Medical Center
- Inspection Date: 2008-06-19
- Product Type: Drugs
- Office Name: New York District Office
- Summary: On December 22, 2008, the FDA issued a Warning Letter to Kreitchman PET Center following an inspection from June 3 to June 19, 2008. The inspection revealed significant deviations from USP compounding standards and official monographs for PET drugs (Fludeoxyglucose (FDG) F 18 Injection, Ammonia N 13 Injection, Water O 15 Injection, and Oxygen O 15 Gas), rendering the products adulterated under Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

The FDA found the August 18, 2008, response to the FDA-483 inadequate, noting many repeat violations from a 2004 inspection. Deficiencies were identified in Quality, Production, Laboratory, and Facilities and Equipment systems. Key violations included:
1.  Failure to investigate unacceptable quality control test results (e.g., OOS sterility for FDG lot F051508-1, OOS residual solvents for FDG lot F052208-1) and document outcomes, with retesting performed without invalidating the first test.
2.  Failure to reject out-of-specification batches (e.g., FDG batch F072607-1 for acetonitrile), maintain raw analytical data, and conduct verification studies for revised compounding procedures.
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## Related Officers

- [Otto D. Vitillo](https://www.keypedia.com/people/otto-d-vitillo/362f7863-2591-40bd-8680-b59819da4798)

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