Drug factory · FDA FEI 3010047167

All Pharma, LLC

Miami Lakes, Florida, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

Problems found, fixed voluntarily at FDA's last inspection, Dec 22, 2021.

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

2 drug inspections on record since 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Ended	Result	Program	Problems noted
Dec 22, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 15, 2019	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.

Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Equipment construction - reactive surfaces 21 CFR 211.65(a)
Equipment surfaces that contact components are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
Components withheld from use pending release 21 CFR 211.84(a)
Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.