FDA Inspection 784512 — Coral Rock Man, Inc.
The FDA completed an inspection of Coral Rock Man, Inc. on June 1, 2012 in Key Colony Beach, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 1, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Key Colony Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15623 | 21 CFR 111.180(b)(2) | Records - receiving; components, packaging, labels, products |
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 16007 | 21 CFR 111.135 | Quality control operations - product complaints |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |