FDA Inspection
Hanaim International LLCHanaim International LLC – FDA Inspection, Oct 2, 2017
Record Details
This FDA Inspection record concerns Hanaim International LLC, with an inspection on October 2, 2017, issued by the New Jersey District Office, covering human drugs.
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ID · 2a51368c-7774-4adb-b55a-8f17d92152b4
Inspection Facts
- Inspection number
- 1027345
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(a)Lack of quality control unit
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