FDA Inspection 987238 — LabChemS Corp.
The FDA completed an inspection of LabChemS Corp. on Oct 6, 2016 in Mayaguez, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 6, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mayaguez, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |