FDA Inspection 1035012 — BioLyte Laboratories, LLC
The FDA completed an inspection of BioLyte Laboratories, LLC on Dec 15, 2017 in Grand Rapids, MI. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 15, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grand Rapids, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |