Drug factory · FDA FEI 1000123092

Arcet Equipment Company dba Arc3 Gases North

13320 Ramblewood Dr, Chester, VA, United States

Problems found, fixed voluntarily at FDA's last inspection, May 18, 2010.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

1 drug inspection on record since 2010: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Nitrogen	Makes it	Arcet Equipment Company dba Arc3 Gases North	59788-002
Oxygen	Makes it	Arcet Equipment Company dba Arc3 Gases North	59788-001

Ended	Result	Program	Problems noted
May 18, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	2

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity of drug products.
GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.

Registered with FDA for: manufacture.