FDA Inspection
JT Cosmetics & Chemicals Pvt Ltd.JT Cosmetics & Chemicals Pvt Ltd. – FDA Inspection, Feb 28, 2018
Record Details
This FDA Inspection record concerns JT Cosmetics & Chemicals Pvt Ltd., with an inspection on February 28, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 085449a2-ca1c-4846-9125-7abbc663753b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1042595
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
18- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.194(a)(1)Description and Identification of Samples
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.170(b)Annual visual exams of drug products
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