FDA Inspection 989774 — Coty Lancaster SAM
The FDA completed an inspection of Coty Lancaster SAM on September 16, 2016 in Monaco. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 16, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Monaco (Monaco)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1393 | 21 CFR 211.103 | Yield calculations not verified by 2nd person |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2400 | 21 CFR 211.194(a)(3) | Statement of Sample Weights and Measures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |