FDA Inspection 664406 — Medecor Pharma, LLC
The FDA completed an inspection of Medecor Pharma, LLC on May 26, 2010 in Baton Rouge, LA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 26, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baton Rouge, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |