FDA Inspection 1021292 — Schrofner Cosmetics Gmbh
The FDA completed an inspection of Schrofner Cosmetics Gmbh on July 19, 2017 in Salzburg. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 32 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 19, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salzburg (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1726 | 21 CFR 211.86 | Rotation of components/containers/closures |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 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 |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 3560 | 21 CFR 211.56(a) | Trash and organic waste timely disposal |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |