FDA Inspection 928538 — ScienceLab.Com, Inc.
The FDA completed an inspection of ScienceLab.Com, Inc. on August 26, 2015 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 26, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3550 | 21 CFR 211.46(c) | Exhaust systems inadequate to control air contamination |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |