FDA Inspection 1009621 — Cramer Products Inc
The FDA completed an inspection of Cramer Products Inc on April 14, 2017 in Gardner, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gardner, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2406 | 21 CFR 211.194(a)(8) | Identification of Person Performing Review of Lab Records |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |