FDA Inspection
HanBangMeIn Cosmetics HBMICHanBangMeIn Cosmetics HBMIC – FDA Inspection, May 4, 2018
Record Details
This FDA Inspection record concerns HanBangMeIn Cosmetics HBMIC, with an inspection on May 4, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · ed7c7921-f8a4-4b9e-8a8a-1e890ce21d12
Inspection Facts
- Inspection number
- 1050624
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
25- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.134(c)Examinations documented
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.150(b)Recall facilitation
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