FDA Inspection 1203838 — American Softgels, Inc.
The FDA completed an inspection of American Softgels, Inc. on April 27, 2023 in Loyalhanna, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 22 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 27, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Loyalhanna, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15630 | 21 CFR 111.180(b)(3)(i) | Document - required operation |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15647 | 21 CFR 111.460(b) | Hold - in-process material; temperature, humidity, light |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 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 |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15898 | 21 CFR 111.83(b)(1) | Reserve sample -container-closure system |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |