FDA Inspection
SnugZ USA, Inc.SnugZ USA, Inc. – FDA Inspection, May 1, 2026
Record Details
This FDA Inspection record concerns SnugZ USA, Inc., with an inspection on May 1, 2026, issued by the Denver District Office, covering human drugs.
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ID · 242d7f6a-607d-4605-a757-3fa9dd12378a
Inspection Facts
- Inspection number
- 1315042
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(2)Component written specification
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Other FDA inspections of SnugZ USA, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2025 | Not classified | Denver District Office | |
| September 17, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 30, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SnugZ USA, Inc.
- FDA Inspection 1277549 - 2025-07-08
- FDA Inspection 1151943 - 2021-09-17
- FDA Inspection 1073275 - 2018-11-30
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