FDA Inspection 1229946 — Pharmaxx, Inc
The FDA completed an inspection of Pharmaxx, Inc on Feb 14, 2024 in Murrieta, 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). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 14, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Murrieta, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15423 | 21 CFR 111.15(j) | Trash disposal |
| 15450 | 21 CFR 111.15(f)(3) | Plumbing - source of contamination |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15880 | 21 CFR 111.75(f)(2) | Label - visual examination, review supplier's documentation |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15941 | 21 CFR 111.105(i) | QC required operations production and process control |