1021292

Schrofner Cosmetics Gmbh — FEI 3010632712

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

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
108621 CFR 211.22(b)Adequate lab facilities not available
109821 CFR 211.22(c)Approve or reject procedures or specs
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
139621 CFR 211.42(c)(2)Rejected Material Area
141121 CFR 211.105(b)Distinctive ID or code not recorded in batch record
144821 CFR 211.111Establishment of time limitations
162621 CFR 211.130Procedures are written, and followed
172621 CFR 211.86Rotation of components/containers/closures
172821 CFR 211.87Retest of approved components/containers/closures
176721 CFR 211.137(a)Expiration date lacking
177421 CFR 211.142(a)Quarantine - actual practice
178721 CFR 211.80(a)Procedures To Be in Writing
179721 CFR 211.82(a)Examination on receipt, before acceptance
184221 CFR 211.84(d)(1)Component identity verification
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
188321 CFR 211.165(a)Testing and release for distribution
188621 CFR 211.165(c)Sampling and testing plans not described
194221 CFR 211.180(e)Records reviewed annually
197521 CFR 211.182Written records kept in individual logs
200321 CFR 211.184(c)Individual inventory record
200721 CFR 211.186(a)Signature and checking of records -- 2 persons
204421 CFR 211.196Distribution Record Requirements
356021 CFR 211.56(a)Trash and organic waste timely disposal
360321 CFR 211.160(b)Scientifically sound laboratory controls
362321 CFR 211.170(a)Active ingredient retained sample kept
363221 CFR 211.170(b)Annual visual exams of drug products
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
441821 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination