FDA Inspection 810530 — Benchmark Medical, Inc.
The FDA completed an inspection of Benchmark Medical, Inc. on December 13, 2012 in Salt Lake City, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 13, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1630 | 21 CFR 211.130(b) | Unlabeled filled containers controls |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1941 | 21 CFR 211.180(d) | Reader/Photocopy equipment not made available |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |