Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your quality unit (QU) did not effectively exercise its authority to ensure test procedures and specifications for talc are scientifically sound and appropriate (see 21 CFR 211.160(b)). Furthermore, you did not demonstrate that your firm’s QU has adequate oversight of your contract testing facility.
Passage 2Furthermore, our review indicates that your QU failed to investigate data discrepancies associated with identification testing for talc.
Passage 3Your firm released talc component lot (b)(4) that did not meet the specification for identity.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 211.22
- 21 CFR 211.192
- 21 CFR 211.160(b)
- 21 CFR 211.84(d)
- 21 CFR 211.84(e)