FDA Inspection
Phoenix Wipes IncPhoenix Wipes Inc – FDA Inspection, Dec 19, 2023
Record Details
This FDA Inspection record concerns Phoenix Wipes Inc, with an inspection on December 19, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 82eb30c6-0792-4a4e-aa44-4ea0ab907df1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225416
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
18- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
Showing 10 of 18 citations.
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.