Drug factory · FDA FEI 3004378621

Super Care, LLC

16017 Valley Blvd, City of Industry, CA, United States

Problems found, fixed voluntarily at FDA's last inspection, Oct 22, 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	Super Care, LLC	68470-1001

Ended	Result	Program	Problems noted
Oct 22, 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.

Distinctive ID or code not recorded in batch record 21 CFR 211.105(b)
The batch records do not record the distinctive identification number and name of equipment to identify major equipment to show the specific equipment used in the manufacture of a batch of a 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 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.
Quarantine of Rejected Components et. al. 21 CFR 211.89
Rejected drug product containers are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.

Registered with FDA for: manufacture.