1151943
SnugZ USA, Inc. — FEI 3009188709
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 17, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Jordan, UT (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1818 | 21 CFR 211.84(c)(2) | Appropriate Opening of Component Containers |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4576 | 21 CFR 211.192 | No written record of investigation |