FDA Inspection 979672 — 4E Global, S.A.P.I. De C.V.
The FDA completed an inspection of 4E Global, S.A.P.I. De C.V. on Jul 8, 2016 in Tultitlan De Mariano Escobedo. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 8, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tultitlan De Mariano Escobedo (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 17743 | 21 CFR 212.30(b) | Equipment procedures overall |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 3961 | 21 CFR 58.81(c) | SOPs: availability |
| 4370 | 21 CFR 211.188(b)(10) | Records of any sampling performed |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |