FDA Inspection 725660 — SPF Consulting Labs, Inc.
The FDA completed an inspection of SPF Consulting Labs, Inc. on May 20, 2011 in Pompano Beach, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 20, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pompano Beach, 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 |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1393 | 21 CFR 211.103 | Yield calculations not verified by 2nd person |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2200 | 21 CFR 211.186(b)(4) | Variation in the Amount of Components Used |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |