FDA Inspection
ASA Universal Inc. dba: SonageASA Universal Inc. dba: Sonage – FDA Inspection, Jun 19, 2018
Record Details
This FDA Inspection record concerns ASA Universal Inc. dba: Sonage, with an inspection on June 19, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7a59b94a-9840-4682-82e3-02a7741b32dd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1056177
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.137(d)Expiration date location on labeling
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.134(c)Examinations documented
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of ASA Universal Inc. dba: Sonage
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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