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# CGMP Deviations at CTX Lifesciences
- URL: https://www.fdaweb.com/cgmp-deviations-at-ctx-lifesciences/
- Published: 2019-08-27T12:00:00.000Z
- Updated: 2026-09-15T01:46:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144867

A 211-2/16 FDA inspection at CTX Lifesciences, Surat, Gujarat, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A just-released 7/12 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ctx-lifesciences-private-ltd-577416-07122019?ref=fdaweb.com) says specific deviations were: 

- failing to ensure that water used in the redacted manufacturing steps of a non-sterile API intended for a sterile drug product is monitored and controlled for total microbial counts, objectionable organisms, and endotoxins; and
- failing to adequately investigate out-of-specification results and implement appropriate corrective actions.

CTX was told to respond with a list of steps taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.