FDA Inspection
Ultrum Labs LLCUltrum Labs LLC – FDA Inspection, Oct 16, 2023
Record Details
This FDA Inspection record concerns Ultrum Labs LLC, with an inspection on October 16, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c4f304d7-f531-4e1e-bf90-779e36548361
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220528
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(a)Components withheld from use pending release
- 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(b)SOPs not followed / documented
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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