Drug factory · FDA FEI 1419861

Precision Dose Inc.

722 Progressive Lane, South Beloit, IL, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 11, 2025.

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

7 drug inspections on record since 2009: 4 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Ended	Result	Program	Problems noted
Sep 11, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jan 28, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 12, 2017	No problems found	Bioresearch Monitoring	—
Jan 27, 2017	No problems found	Drug Quality Assurance	—
Oct 3, 2011	No problems found	Drug Quality Assurance	—
May 2, 2011	No problems found	Drug Quality Assurance	—
Nov 24, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	2

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

Identification of containers, lines, equipment 21 CFR 211.105(a)
All compounding and storage containers, processing lines and major equipment used during the production of a batch of drug product is not properly identified at all times to indicate contents and the phase of processing of the batch.
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.

Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations.
Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.

Registered with FDA for: repack.