Precision Dose Inc.

FDA establishment 1419861, South Beloit, Illinois, United States. Part of Precision Dose's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.

Inspections: 7
Official action indicated: 0
Last inspection ended: Sep 11, 2025
Warning letters: 0
Recalls since 2016: 6

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

12019

02021

02023

12025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

7 inspections, newest first


Sep 11, 2025	Drugs · Drug Quality Assurance	2 cited references 21 CFR 211.105(a). Identification of containers, lines, equipment 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. 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.	Voluntary Action Indicated (VAI)
Jan 28, 2019	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
May 12, 2017	Drugs · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Jan 27, 2017	Drugs · Drug Quality Assurance	None posted	No Action Indicated (NAI)
Oct 3, 2011	Drugs · Drug Quality Assurance	None posted	No Action Indicated (NAI)
May 2, 2011	Drugs · Drug Quality Assurance	None posted	No Action Indicated (NAI)
Nov 24, 2009	Drugs · Drug Quality Assurance	2 cited references 21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations. 21 CFR 211.192. Extent of discrepancy, failure investigations 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.	Voluntary Action Indicated (VAI)

Recalls

6 drug, device and biologic recalls since 2016, newest first; 0 Class I


Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL…Drug · D-0741-2026	Class II	Jul 14, 2026
Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in…Drug · D-0094-2022 · 2 products	Class II	Nov 1, 2021
Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC…Drug · D-0228-2021	Class II	Jan 1, 2021
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x…Drug · D-1004-2020	Class II	Nov 13, 2019
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count…Drug · D-0057-2018	Class III	Sep 25, 2017
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S.…Drug · D-1037-2017	Class II	Jul 5, 2017

Identifiers

FEI number: 1419861
FDA firm profile: Data Dashboard
Inspection program: 7356.002, Drug Manufacturing Inspections
Company: Precision Dose

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports