FDA Inspection 1101923 — Mediervas Industria De Produtos Farmaceuticos
The FDA completed an inspection of Mediervas Industria De Produtos Farmaceuticos on Sep 13, 2019 in Sorocaba. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 13, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Sorocaba (Brazil)
Citations
| ID | CFR | Description |
|---|---|---|
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15556 | 21 CFR 111.260(j)(2)(iv) | Batch record - initials; verifying component |
| 15558 | 21 CFR 111.260(k)(1) | Batch record - identifier; packaging |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15948 | 21 CFR 111.110 | Quality control operations - laboratory operations |
| 16007 | 21 CFR 111.135 | Quality control operations - product complaints |
| 16067 | 21 CFR 111.35(b)(1)(ii) | Procedures - equipment; calibrating, inspecting, checking |