570569
Lyne Laboratories, Inc. — FEI 1000513191
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 26, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brockton, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1819 | 21 CFR 211.84(c)(3) | Sterile/Aseptic Techniques for Sampling |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3594 | 21 CFR 211.110(d) | Rejected in-process materials not quarantined |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |