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FDA Inspection
•Globo Pharma Inc•July 28, 2023

Globo Pharma Inc – FDA Inspection, Jul 28, 2023

Record Details

This FDA Inspection record concerns Globo Pharma Inc, with an inspection on July 28, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Globo Pharma Inc
Inspection Date
July 28, 2023
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
People
  • Jose Perez-Soto (Issuing Officer)
  • Moraima J. Ramos-Valle (Investigator)
View Company Profile

ID · c2562910-7953-47c3-bbd1-682ff21c7348

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1211491
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ
Outcome
Form 483 issued

FDA Citations

22
  1. 21 CFR 111.210(h)(3)Specific actions; packaged, labeled
  2. 21 CFR 111.205(a)Master manufacturing record - unique formulation
  3. 21 CFR 111.70(b)(1)Specifications - component identity
  4. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  5. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  6. 21 CFR 111.16Written procedures - cleaning
  7. 21 CFR 111.353Manufacturing operations - written procedures
  8. 21 CFR 111.255(b)Batch record - complete
  9. 21 CFR 111.20(d)(1)(i)Floors, walls, ceilings
  10. 21 CFR 111.10(b)(1)Outer garments

Showing 10 of 22 citations.

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Other FDA inspections of Globo Pharma Inc

2
DateClassificationOfficeProject area
June 21, 2024VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
July 2, 2019Not classifiedFlorida District Office
Other documents for Globo Pharma Inc
  • FDA Inspection 1241516 - 2024-06-21
  • FDA Inspection 1095015 - 2019-07-02

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