FDA Inspection 1306884 — Lyne Laboratories, Inc.
The FDA completed an inspection of Lyne Laboratories, Inc. on March 10, 2026 in Brockton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brockton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |