FDA Inspection 1073905 — Laboratorios Jaloma S.A. De C.V.
The FDA completed an inspection of Laboratorios Jaloma S.A. De C.V. on Dec 7, 2018 in Guadalajara. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 7, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Guadalajara (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |