651821
Power Line Packaging, Inc. — FEI 3000718719
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 8, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Conshohocken, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3550 | 21 CFR 211.46(c) | Exhaust systems inadequate to control air contamination |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |