The Belport Company, Inc DBA Gingi-Pak
Form 483 issued November 12, 2021 · Camarillo, California
- Investigator
- Taichun Qin
- Observations
- 7
- Pages
- 6
- FEI number
- 2014676
In short: On November 12, 2021, FDA issued a Form 483 with 7 observations to The Belport Company, Inc DBA Gingi-Pak in Camarillo, California (FEI 2014676). The investigator was Taichun Qin. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 02
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 03
Written production and process control procedures are not followed in the execution of production…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmThe Belport Company, Inc DBA Gingi-Pak history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Belport Company, Inc DBA Gingi-Pak?
FDA listed 7 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected The Belport Company, Inc DBA Gingi-Pak?
Taichun Qin is named on this Form 483. Each investigator has a profile showing what they cite most.
When was The Belport Company, Inc DBA Gingi-Pak inspected by FDA?
This Form 483 is dated November 12, 2021.
How do I get the full Form 483 for The Belport Company, Inc DBA Gingi-Pak?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.