FDA Inspection 1096660 — Sasa Cosmetics ACS Ltd
The FDA completed an inspection of Sasa Cosmetics ACS Ltd on July 2, 2019 in Giv'At Oz. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 2, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Giv'At Oz (Israel)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |