FDA Inspection
Formula CorpFormula Corp – FDA Inspection, Jun 15, 2018
Record Details
This FDA Inspection record concerns Formula Corp, with an inspection on June 15, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ecb4d4c9-5238-4611-9880-5f8afc5481f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055802
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Formula Corp
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2024 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| June 26, 2015 | NAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| February 14, 2014 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| May 9, 2012 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Formula Corp
- FDA Inspection 1256181 - 2024-12-11
- FDA Inspection 931405 - 2015-06-26
- FDA Inspection 867363 - 2014-02-14
- FDA Inspection 785116 - 2012-05-09
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