FDA Inspection
Gingi-Pak A Division of the Belport Co., IncGingi-Pak A Division of the Belport Co., Inc – FDA Inspection, Jun 9, 2017
Record Details
This FDA Inspection record concerns Gingi-Pak A Division of the Belport Co., Inc, with an inspection on June 9, 2017, issued by the Los Angeles District Office, covering human drugs.
- Inspection Date
- June 9, 2017
- Product Type
- Human Drugs
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ID · c244d7e1-31cf-4070-a34c-b32357131350
Inspection Facts
- Inspection number
- 1013526
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
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Other FDA inspections of Gingi-Pak A Division of the Belport Co., Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 23, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 30, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 14, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gingi-Pak A Division of the Belport Co., Inc
- FDA Inspection 1156779 - 2021-11-12
- FDA Inspection 1082109 - 2019-01-23
- FDA Inspection 896678 - 2014-09-30
- FDA Inspection 775564 - 2012-03-14
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