FDA Inspection 1187520 — Royal Chemical Company
The FDA completed an inspection of Royal Chemical Company on November 8, 2022 in E Stroudsburg, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 8, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- E Stroudsburg, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |