FDA Inspection
SnugZ USA, Inc.SnugZ USA, Inc. – FDA Inspection, Sep 17, 2021
Record Details
This FDA Inspection record concerns SnugZ USA, Inc., with an inspection on September 17, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- SnugZ USA, Inc.
- Inspection Date
- September 17, 2021
- Product Type
- Drugs
View Company Profile
ID · d8740e2a-7eea-4691-9e24-828ef6fce1a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1151943
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
18- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.160(b)Scientifically sound laboratory controls
Showing 10 of 18 citations.
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Other FDA inspections of SnugZ USA, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2026 | Not classified | Denver District Office | Drug Quality Assurance |
| July 8, 2025 | Not classified | Denver District Office | |
| November 30, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SnugZ USA, Inc.
- FDA Inspection 1315042 - 2026-05-01
- FDA Inspection 1277549 - 2025-07-08
- FDA Inspection 1073275 - 2018-11-30
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