FDA Inspection 730338 — Helget Gas Products, Inc.
The FDA completed an inspection of Helget Gas Products, Inc. on Jun 3, 2011 in Bensenville, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 3, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bensenville, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2427 | 21 CFR 110.80(b)(9) | Proper disposal of adulterated product |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |