FDA Inspection
Gingi-Pak A Division of the Belport Co., IncGingi-Pak A Division of the Belport Co., Inc – FDA Inspection, Nov 12, 2021
Record Details
This FDA Inspection record concerns Gingi-Pak A Division of the Belport Co., Inc, with an inspection on November 12, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 12, 2021
- Product Type
- Drugs
View Company Profile
ID · 17be2adc-9eae-4e94-9044-e54d22235c56
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1156779
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.130(e)Packaging line inspection documentation
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gingi-Pak A Division of the Belport Co., Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 9, 2017 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| 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 1082109 - 2019-01-23
- FDA Inspection 1013526 - 2017-06-09
- FDA Inspection 896678 - 2014-09-30
- FDA Inspection 775564 - 2012-03-14
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.