Swabplus, L.P. – FDA Inspection, Apr 11, 2019

Record Details

This FDA Inspection record concerns Swabplus, L.P., with an inspection on April 11, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Swabplus, L.P.
Inspection Date: April 11, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Diane R. Weidley (FDA Associated Person)
Marcus F. Yambot (FDA Associated Person)

View Company Profile

ID · ce0f36c2-eb06-4849-9703-07987c204d1d

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1087365
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued
Enforcement: Warning Letter

FDA Citations

21 CFR 211.113(a)Procedures for non-sterile drug products
21 CFR 211.125(a)Strict control not exercised over labeling issued
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.165(a)Testing and release for distribution
21 CFR 211.165(e)Test methods
21 CFR 211.180(e)(1)Review of representative number of batches
21 CFR 211.192No written record of investigation
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.67(b)Written procedures not established/followed
21 CFR 211.68(b)Backup file not maintained

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Swabplus, L.P.

Date	Classification	Office	Project area
August 1, 2023	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance
October 15, 2021	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance
June 30, 2016	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
March 28, 2014	NAI	Center for Veterinary Medicine	Monitoring of Marketed Animal Drugs, Feed, and Devices
July 21, 2011	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance