FDA Inspection 1241018 — Penn Herb Company, Ltd.
The FDA completed an inspection of Penn Herb Company, Ltd. on June 13, 2024 in Philadelphia, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 26 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 13, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15510 | 21 CFR 111.27(a)(7) | Compressed air, gases |
| 15512 | 21 CFR 111.27(d)(1) | Equipment - taken apart |
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15758 | 21 CFR 111.205(c) | Master manufacturing record: 1 year, 2 years |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15902 | 21 CFR 111.83(b)(4) | Reserve sample - twice the quantity |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |
| 16001 | 21 CFR 111.130(a) | Quality control returned dietary supplement; material review, disposition |