FDA Inspection 1100069 — Valentin Management, Inc.
The FDA completed an inspection of Valentin Management, Inc. on August 21, 2019 in Lancaster, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 21, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lancaster, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 16014 | 21 CFR 111.140(b)(1) | QC ops; written procedures; material review, disposition |