FDA Inspection 790122 — Xymogen Manufacturing
The FDA completed an inspection of Xymogen Manufacturing on July 6, 2012 in Orlando, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 6, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |