Drug factory · FDA FEI 1025636

Airgas Usa, LLC

7280 Nw 58Th St, Miami, FL, United States

Problems found, fixed voluntarily at FDA's last inspection, Jul 22, 2022.

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

4 drug inspections on record since 2010: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Ended	Result	Program	Problems noted
Jul 22, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	2
Oct 18, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	5
Aug 29, 2014	No problems found	Drug Quality Assurance	—
Aug 25, 2010	No problems found	Drug Quality Assurance	—

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

Records reviewed annually 21 CFR 211.180(e)
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures and specifications.
Identification of persons involved, each significant step 21 CFR 211.188(b)(11)
Batch production and control records do not include the identification of the persons performing and checking each significant step in the operation, for each batch of drug product produced.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located to facilitate operations for its cleaning and maintenance.

Registered with FDA for: manufacture.