FDA Inspection
SOFTAP INCSOFTAP INC – FDA Inspection, Dec 11, 2023
Record Details
This FDA Inspection record concerns SOFTAP INC, with an inspection on December 11, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b0370a81-8793-482c-984e-6f504bf127ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224657
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.180(e)Records reviewed annually
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