Drug factory · FDA FEI 1629694

Professional Compounding Centers of America dba PCCA

9901 South Wilcrest, Houston, TX, United States

Problems found, fixed voluntarily at FDA's last inspection, Apr 21, 2023.

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

6 drug inspections on record since 2009: 2 with no problems, 2 with problems fixed voluntarily, 2 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Naltrexone and Triamcinolone	Repackages it	Complete Pharmacy and Medical Solutions	69364-3143

Ended	Result	Program	Problems noted
Apr 21, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 29, 2019	Serious problems, FDA action	Drug Quality Assurance	—
Mar 4, 2019	No problems found	Drug Quality Assurance	—
Feb 23, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	3
Mar 14, 2012	No problems found	Drug Quality Assurance	—
Jun 11, 2009	Serious problems, FDA action	Drug Quality Assurance	—

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

SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions.
Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: relabel; repack.