FDA Inspection
FirstCham Co., Ltd.FirstCham Co., Ltd. – FDA Inspection, Oct 27, 2023
Record Details
This FDA Inspection record concerns FirstCham Co., Ltd., with an inspection on October 27, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9d313931-6986-4952-92a3-66af62a9cf8c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1221171
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
16- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.48(a)Plumbing System Defects
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.166(a)Lack of written stability program
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