FDA Inspection
Helget Gas Products IncHelget Gas Products Inc – FDA Inspection, Jun 7, 2017
Record Details
This FDA Inspection record concerns Helget Gas Products Inc, with an inspection on June 7, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Rita K. Vick (Issuing Officer)
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ID · 2b0690ee-78b9-4a75-b44f-f921c5362f88
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013173
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Helget Gas Products Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 22, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 12, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 4, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 1, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Helget Gas Products Inc
- FDA Inspection 1259742 - 2025-07-29
- FDA Inspection 923302 - 2015-04-22
- FDA Inspection 759512 - 2011-12-12
- FDA Inspection 696464 - 2010-11-04
- FDA Inspection 616341 - 2009-10-01
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