Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
FDA establishment 3000215862, Brea, California, United States. Part of Carolina Liquid Chemistries's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 8
Official action indicated: 1
Last inspection ended: Feb 17, 2026
Warning letters: 1
Recalls since 2016: 2
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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.
02018Inspections0
120192019Inspections1vs 2018+1
12020Inspections1vs 2019+0
020212021Inspections0vs 2020−1
02022Inspections0vs 2021+0
020232023Inspections0vs 2022+0
02024Inspections0vs 2023+0
020252025Inspections0vs 2024+0
12026Inspections1vs 2025+1
020272027 to dateInspections0
Most Cited at This Site
Inspections citing each reference
ISO 13485:2016 Clause 8.2.2: Complaint handling procedures lack required elements1
ISO 13485:2016 Clause 7.4.3: Purchased product verification activities not established or implemented1
ISO 13485:2016 Clause 4.1.2: Risk-based approach not applied to QMS processes1
ISO 13485:2016 Clause 8.2.2. Complaint handling procedures lack required elements Procedures for timely complaint handling do not adequately include requirements and responsibilities for receiving and recording information.
ISO 13485:2016 Clause 7.4.3. Purchased product verification activities not established or implemented The inspection or other activities necessary for ensuring that purchased product meets specified purchasing requirements were not adequately established and implemented.
ISO 13485:2016 Clause 4.1.2. Risk-based approach not applied to QMS processes A risk-based approach to the control of the appropriate processes needed for the quality management system has not been adequately applied.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis was not performed.
21 CFR 820.30(h). Design transfer - Lack of or inadequate procedures Procedures were not implemented to ensure that the device design was correctly transferred into production.
21 CFR 820.30(d). Design output - review and approval The approval of design output (including the date and signature of the individual approving the output) was not documented.
21 CFR 820.30(g). Design validation - documentation The results of design validation, including methods and the date, were not documented and filed in the design history file.
21 CFR 820.30(e). Design review - documentation The design review results, including identification of the design, the date, and the individual performing the review, were not documented and filed in the design history file.
21 CFR 820.30(b). Design plans- updated Design plans were not reviewed and approved as needed as the design and development evolved.
21 CFR 820.184(d). Acceptance records The device history record does not include complete acceptance records that demonstrate the device is manufactured in accordance with the device master record.
21 CFR 820.30(c). Design input approval documentation The approval of design input requirements (including the date and signature of the individual approving the requirements) was not documented.
21 CFR 820.100(b). Documentation Corrective and preventive action activities have not been documented, including investigations of causes of nonconformities and implementation of corrective and preventive actions.
21 CFR 820.130. Packaging Device packaging and/or shipping containers are not designed and constructed well enough to protect the device from damage during processing, storage, handling, and distribution.
21 CFR 820.198(e)(7). Corrective action taken Records of complaint investigations do not include any corrective action taken.
21 CFR 820.198(a)(2). Oral complaints Complaint handling procedures have not been defined, documented, and completed to ensure that all oral complaints are documented upon receipt.
21 CFR 820.198(a). General Complaint handling procedures for receiving, reviewing, and evaluating complaints have not been completed.
21 CFR 809.20(b). Compliance with GMP In vitro diagnostic products are not being manufactured in accordance with the good manufacturing practices set forth in the Quality System Regulation.
21 CFR 809.10(a)(9)(i). Lot/Control Numbers - multiple unit product Lot or control numbers on a multiple unit in vitro diagnostic product label and outside container do not permit tracing of the identity of the individual units.
21 CFR 820.180. Legibility Required records are not legible.
21 CFR 820.181(a). DMR device specifications The device master record does not include or refer to the location of all and device specifications.
21 CFR 820.198(b). Review and evaluation for investigation Not all complaints have been reviewed and evaluated to determine whether an investigation is necessary.
21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements were not implemented.
Voluntary Action Indicated (VAI)
Oct 8, 2008
Devices · Compliance: Devices
None posted
No Action Indicated (NAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
Brea, California, United States. Part of