FDA Inspection
Thai Nakorn Patana Co., Ltd,Thai Nakorn Patana Co., Ltd, – FDA Inspection, Aug 4, 2023
Record Details
This FDA Inspection record concerns Thai Nakorn Patana Co., Ltd,, with an inspection on August 4, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e07675eb-72ca-4965-ace5-8c674b35e939
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1214709
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
12- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
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