FDA Inspection 1065826 — Living Large Research Peptides LLC
The FDA completed an inspection of Living Large Research Peptides LLC on Sep 6, 2018 in Lexington, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 19 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 6, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lexington, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15455 | 21 CFR 111.20(a) | Physical plant - size, construction, design |
| 15458 | 21 CFR 111.20(d)(1)(i) | Floors, walls, ceilings |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15582 | 21 CFR 111.155(e) | Components - contamination, deterioration, mix-ups |
| 15584 | 21 CFR 111.155(d)(1) | Components - identify lot produced |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15842 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16007 | 21 CFR 111.135 | Quality control operations - product complaints |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |