FDA Inspection 680662 — Pharmachem Laboratories, LLC.
The FDA completed an inspection of Pharmachem Laboratories, LLC. on August 17, 2010 in Kearny, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 17, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Kearny, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15908 | 21 CFR 111.90(b)(1) | Reprocessed, dietary supplement - no material review |