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1136484

Toyobo Co. Ltd. — FEI 1000251214

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 25, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Otsu (Japan)

Facility

Other inspections at this facility

  • 1201609 (VAI Sat Feb 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100505 (VAI Tue Jul 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
116321 CFR 211.28(b)Habits of good sanitation & health
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
437621 CFR 211.188(b)(4)Weights and measures of components used
440221 CFR 211.192Written record of investigation incomplete
440621 CFR 211.194(a)(2)Suitability of testing methods verified