595774

GDMI, Inc — FEI 1640745

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 29, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Garland, TX (United States)

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145021 CFR 211.113(a)Procedures for non-sterile drug products
145421 CFR 211.115(a)Reprocessing procedures not written or followed
188621 CFR 211.165(c)Sampling and testing plans not described
191421 CFR 211.166(a)Lack of written stability program
197521 CFR 211.182Written records kept in individual logs
200921 CFR 211.188Prepared for each batch, include complete information
202821 CFR 211.192Extent of discrepancy, failure investigations
203321 CFR 211.194(c)Testing and standardization of standards et. al.
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
434321 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
438921 CFR 211.198(a)Procedures to be written and followed
441721 CFR 211.204Associated batches implicated, investigated
900121 CFR 211.22(a)Lack of quality control unit