FDA Inspection 699374 — New SPS Crossfolds, LLC
The FDA completed an inspection of New SPS Crossfolds, LLC on November 29, 2010 in Commack, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 19 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 29, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Commack, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2015 | 21 CFR 211.188(b)(3) | Identification of Components and In-Process Materials |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2406 | 21 CFR 211.194(a)(8) | Identification of Person Performing Review of Lab Records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3604 | 21 CFR 211.160(b)(1) | Determination of conformance |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |