Helget Gas Products, Inc.
Form 483 issued May 25, 2023 · BRIDGETON, Missouri
- Observations
- 8
- Pages
- 6
- FEI number
- 3002587812
In short: On May 25, 2023, FDA issued a Form 483 with 8 observations to Helget Gas Products, Inc. in BRIDGETON, Missouri (FEI 3002587812). Most observations concern quality system and packaging & labeling.
At a glance
Quality system and packaging & labeling account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Samples of representative units were not visually examined for correct labeling at the…
- 02
Procedures describing in sufficient detail the controls employed for the issuance of…
- 03
The responsibilities applicable to the quality contro! unit…
- 04
Procedures describing the handling of all written and oral complaints regarding a drug product are…
This inspection in context
Questions about this 483
What did FDA find at Helget Gas Products, Inc.?
FDA listed 8 observations on this Form 483, mostly about quality system, packaging & labeling and laboratory controls. The opening words of each observation are shown on this page.
When was Helget Gas Products, Inc. inspected by FDA?
This Form 483 is dated May 25, 2023.
How do I get the full Form 483 for Helget Gas Products, Inc.?
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.