Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your firm did not address the concerns associated with the lack of endotoxin control during the production process and then release of intrathecal drug products when the **(b)(4)** equipment is not available for testing. Without endotoxin controls (such as endotoxin data on CoAs for bulk drug substances and other components, finished product endotoxin testing, etc.), there are no assurances that intrathecal drug products are safe for their intended use.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 200.10(b)
- 21 CFR 201.115
- 21 CFR 210.1(b)