FDA Inspection
Esteem Products LTDEsteem Products LTD – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns Esteem Products LTD, with an inspection on June 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 967898b1-f2a5-4d47-9a59-22e8bcc45bdd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014237
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 111.70(f)Specifications - product received for packaging, labeling
- 21 CFR 111.475(a)Records - holding, distribution: readily available
- 21 CFR 111.180(b)(1)Written procedures - product received
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.140(b)(1)Records - quality control operations; responsibilities
- 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
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Other FDA inspections of Esteem Products LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2016 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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