FDA 483 - Kenvue Brands LLC - February 19, 2008

The FDA Form 483 documents observations from an inspection related to deficiencies in complaint records and investigations. The facility's complaint records are cited for not including complete investigation findings and follow-up.

Specific violations include: 1. **Incomplete Investigations:** * An investigation into two complaints of (b)(4) found in (b)(4) bottles (ON (b)(4)) was incomplete. It failed to include a medical evaluation of risk from ingesting (b)(4) instead of (b)(4). Additionally, ON (b)(4) was initiated approximately six months after the second complaint. * An investigation into a complaint of (b)(4) found in a (b)(4) bottle was incomplete. It lacked evaluation of products packaged on parallel or adjacent lines during lot (b)(4) packaging to identify the source of mix-up. An additional investigation on 2/14/08 determined (b)(4) was packaged concurrently with (b)(4). * An investigation into a (b)(4) complaint received on (b)(4) was incomplete. It lacked evaluation of products manufactured prior to bulk lot (b)(4) and packaged into finished lot (b)(4) using the same processing equipment, to identify the source of mix-up. There was also no assessment of products packaged on parallel or adjacent lines during lot (b)(4) packaging.

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