FDA Inspection 968466 — Mappel Industria de Embalagens S.A.
The FDA completed an inspection of Mappel Industria de Embalagens S.A. on April 15, 2016 in Diadema. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 15, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Diadema (Brazil)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |