FDA Inspection 741604 — MDR Fitness Corp.
The FDA completed an inspection of MDR Fitness Corp. on Aug 22, 2011 in Sunrise, FL. 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). 14 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 22, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sunrise, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 15826 | 21 CFR 111.65 | Quality control - packaged, labeled |
| 15920 | 21 CFR 111.95(b)(1) | Records - established specifications |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |