FDA Inspection 833513 — Xymogen Manufacturing
The FDA completed an inspection of Xymogen Manufacturing on May 24, 2013 in Orlando, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 24, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15388 | 21 CFR 111.10(b) | Personnel - hygienic practices |
| 15405 | 21 CFR 111.13(a) | Supervisor - qualified |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |