FDA Inspection 807799 — Laboratorios KEM, S De RL De CV
The FDA completed an inspection of Laboratorios KEM, S De RL De CV on Nov 16, 2012 in Tijuana. 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). 2 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 16, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tijuana (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 15556 | 21 CFR 111.260(j)(2)(iv) | Batch record - initials; verifying component |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |