FDA Inspection 1031932 — Goran Pharma Private Ltd
The FDA completed an inspection of Goran Pharma Private Ltd on November 15, 2017 in Sihor. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 17 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 15, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sihor (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1546 | 21 CFR 211.125(d) | Destruction of excess labels with lot numbers |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |