FDA Inspection 787212 — Corad Healthcare, Inc.
The FDA completed an inspection of Corad Healthcare, Inc. on Jun 8, 2012 in Dellwood, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 19 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 8, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dellwood, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 2200 | 21 CFR 211.186(b)(4) | Variation in the Amount of Components Used |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |