FDA Inspection 901846 — Robinson Pharma, Inc.
The FDA completed an inspection of Robinson Pharma, Inc. on Oct 30, 2014 in Costa Mesa, CA. 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). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 30, 2014
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Costa Mesa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15458 | 21 CFR 111.20(d)(1)(i) | Floors, walls, ceilings |
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15562 | 21 CFR 111.260(l)(1) | Batch record - quality control review; production |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |
| 15980 | 21 CFR 111.123(a)(4) | Quality control operations - material review, disposition decision |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |