FDA Inspection 1098336 — Hit Promotional Products Inc.
The FDA completed an inspection of Hit Promotional Products Inc. on Aug 2, 2019 in Saint Petersburg, FL. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 2, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Petersburg, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 2420 | 21 CFR 211.198(a) | Quality Control Review |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |