Drug factory · FDA FEI 2026523

Calox Inc

3034 Fierro Street, Los Angeles, CA, United States

Problems found, fixed voluntarily at FDA's last inspection, Oct 31, 2014.

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 2014: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Oxygen	Makes it	Calox Inc	51194-123

Ended	Result	Program	Problems noted
Oct 31, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	5

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

Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products.
Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
Results of drug product inspections and examinations 21 CFR 211.188(b)(13)
The batch production and control records are deficient in that they do not include results of drug product examinations and inspections.
Adequate space lacking to prevent mix-ups and contamination 21 CFR 211.42(b)
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between drug product containers and drug products and to prevent contamination.
Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over micro-organisms and dust is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: manufacture.