FDA Inspection 713089 — Lyne Laboratories, Inc.
The FDA completed an inspection of Lyne Laboratories, Inc. on March 25, 2011 in Brockton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 25, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brockton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 4403 | 21 CFR 211.194(b) | Test method modification records do not include |