FDA Inspection 754302 — Theta Brothers Sports Nutrition Inc dba Protein Factory
The FDA completed an inspection of Theta Brothers Sports Nutrition Inc dba Protein Factory on November 8, 2011 in Lakewood, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 8, 2011
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lakewood, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15505 | 21 CFR 111.27(a)(3)(v) | Equipment - protect from contamination |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15585 | 21 CFR 111.155(d)(2) | Components - unique identifier |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 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 |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 16072 | 21 CFR 111.35(b)(3) | Instruments, controls; calibrate date, reference std, method |