FDA Inspection 786248 — Industria Farmaceutica Andromaco S.A. De C.V.
The FDA completed an inspection of Industria Farmaceutica Andromaco S.A. De C.V. on Jun 1, 2012 in Zona Industrial Parque Industrial Toluca 2000. 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). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 1, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Zona Industrial Parque Industrial Toluca 2000 (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |