FDA Inspection
Jalco Cosmetics Pty Ltd.Jalco Cosmetics Pty Ltd. – FDA Inspection, Dec 13, 2017
Record Details
This FDA Inspection record concerns Jalco Cosmetics Pty Ltd., with an inspection on December 13, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e2f08c43-2419-4dcf-ad84-2240d48c032a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1035033
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.67(b)Written procedures not established/followed
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