FDA Inspection
Kremoint Pharma Private LimitedKremoint Pharma Private Limited – FDA Inspection, Jun 20, 2019
Record Details
This FDA Inspection record concerns Kremoint Pharma Private Limited, with an inspection on June 20, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Kara D. Dobbin (Issuing Officer)
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ID · 3446929b-9f8c-4f58-b22b-178a67f938fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094299
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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