FDA Inspection
Shri Kartikeya PharmaShri Kartikeya Pharma – FDA Inspection, Dec 22, 2023
Record Details
This FDA Inspection record concerns Shri Kartikeya Pharma, with an inspection on December 22, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 63a6a471-e6ad-4135-8a83-0b5048a4fed2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225831
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 117.80(a)(2)Appropriate quality control operations
- 21 CFR 117.135(a)(1)Allergen preventive controls - Identify (Written)
- 21 CFR 117.135(a)(1)Process preventive controls - Identify (Written)
- 21 CFR 117.160(a)Process controls - Validation
- 21 CFR 117.135(a)(1)Allergen preventive controls - Identify (Written)
- 21 CFR 117.160(a)Process controls - Validation
- 21 CFR 117.80(a)(2)Appropriate quality control operations
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