Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is a 29% increase over the number of companies cited in the previous year.
Of the 111 citations issued, the most common citation was 'You did not develop an FSVP'.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.
Of the companies cited, 37 should take voluntary actions to correct their managing operations (92.5%). Additionally, three companies had to take regulatory and/or administrative actions (7.5%).
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.
Company Name | Area of Business | Inspection Date | Issue Cited |
---|---|---|---|
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Lack of quality control unit |
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Reports of Analysis (Components) |
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Retest of approved components/containers/closures |
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Control procedures to monitor and validate performance |
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Expiration date lacking |
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Scientifically sound laboratory controls |
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Failing drug products not rejected |
All For Your Cakes, Inc. | Food and Cosmetics | 08/28/2023 | Very small importer assurances, supplier |
Amcor Rigid Packaging USA, LLC | Devices | 01/12/2023 | Evaluation of suppliers, contractors, etc., requirements |
Amcor Rigid Packaging USA, LLC | Devices | 01/12/2023 | Nonconforming product, Lack of or inadequate procedures |
Amcor Rigid Packaging USA, LLC | Devices | 01/12/2023 | Lack of or inadequate complaint procedures |
Anbar Distributions, LLC | Food and Cosmetics | 08/17/2023 | Very small importer assurances, supplier |
Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Quality audits - auditor independence |
Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Procedures not adequately established or maintained |
Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Purchasing controls, Lack of or inadequate procedures |
Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Lack of or inadequate final acceptance procedures |
Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Lack of or inadequate complaint procedures |
Beverage King, LLC | Food and Cosmetics | 07/13/2023 | Manufacturing, processing, packing, holding - Controls |
Beverage King, LLC | Food and Cosmetics | 07/13/2023 | All hazards not considered |
Beverage King, LLC | Food and Cosmetics | 07/13/2023 | Calibration, testing - no records |
Beverage King, LLC | Food and Cosmetics | 07/13/2023 | Records - actual values |
Biscuits & Cookies International | Food and Cosmetics | 08/15/2023 | Supplier approval - document |
Biscuits & Cookies International | Food and Cosmetics | 08/15/2023 | Approved supplier procedures - importer established |
Biscuits & Cookies International | Food and Cosmetics | 08/15/2023 | Supplier verification - establish written procedures |
Biscuits & Cookies International | Food and Cosmetics | 08/15/2023 | Record - English |
Brian Flowers | Drugs | 03/23/2023 | FD-1572, protocol compliance |
Buda Juice, LLC | Food and Cosmetics | 11/14/2023 | HACCP plan - monitoring procedures - none listed |
Buda Juice, LLC | Food and Cosmetics | 11/14/2023 | HACCP plan - corrective action plan not included |
Colgin, Inc. | Drugs | 09/21/2023 | Procedures not in writing, fully followed |
Colgin, Inc. | Drugs | 09/21/2023 | Cleaning / Sanitizing / Maintenance |
Colgin, Inc. | Drugs | 09/21/2023 | Identity Testing of Each Component |
Colgin, Inc. | Drugs | 09/21/2023 | Actual vs. theoretical yields not determined |
Colgin, Inc. | Drugs | 09/21/2023 | Testing and release for distribution |
Creative Liquids, LLC | Food and Cosmetics | 07/20/2023 | Instruments - calibration |
Dentlight, Inc. | Devices | 08/23/2023 | Quality audits - auditor independence |
El Gordo Spices, LLC | Food and Cosmetics | 03/22/2023 | Hazard analysis - Conducted |
Eminent Spine, LLC | Devices | 10/13/2023 | Info evaluated to determine if event was reportable |
Eminent Spine, LLC | Devices | 10/13/2023 | Design Validation - Risk analysis not performed/inadequate |
Eminent Spine, LLC | Devices | 10/13/2023 | Approval, inadequate purchasing data |
Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Donor testing not negative for CD agents |
Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Documentation--determination, by whom, date |
Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Risk factors, clinical evidence |
Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Eligibility not required--warning labels |
First Fitness International, Inc. | Food and Cosmetics | 01/25/2023 | Quality control operations - packaged, labeled; specifications |
Genesis Biosystems, Inc. | Devices | 01/09/2023 | Quality audits - auditor independence |
Genesis Biosystems, Inc. | Devices | 01/09/2023 | Acceptable supplier records, inadequate records |
Genesis Biosystems, Inc. | Devices | 01/09/2023 | Lack of or inadequate complaint procedures |
Grain Market, LLC | Food and Cosmetics | 07/10/2023 | Hazard analysis written |
Grain Market, LLC | Food and Cosmetics | 07/10/2023 | Evaluation - performance, risk |
Grain Market, LLC | Food and Cosmetics | 07/10/2023 | Approved supplier procedures - importer established |
Grain Market, LLC | Food and Cosmetics | 07/10/2023 | Verification activity frequency |
Grain Market, LLC | Food and Cosmetics | 07/10/2023 | Verification activity - appropriate |
Grain Market, LLC | Food and Cosmetics | 07/10/2023 | Verification activity before import, periodically |
Hiland Dairy Foods Company, LLC | Food and Cosmetics | 08/04/2023 | Sanitary operations - Plant sanitation |
JMD, LLC | Food and Cosmetics | 08/07/2023 | Qualifications of individuals |
JMD, LLC | Food and Cosmetics | 08/07/2023 | Pest control |
JMD, LLC | Food and Cosmetics | 08/07/2023 | Record availability |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Quality control - quality, dietary supplement |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Reserve sample - collect, hold |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Written procedures - holding |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Written procedures - returned dietary supplement |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Written procedures - product complaint |
Mannatech Incorporated | Food and Cosmetics | 09/13/2023 | Develop FSVP |
Marriott International, Inc. | Food and Cosmetics | 11/13/2023 | Identification - entry |
Marriott International, Inc. | Food and Cosmetics | 11/13/2023 | Regulatory oversight |
Mary Kay, Inc. | Drugs | 10/27/2023 | Cleaning SOPs/equipment protection |
Mid-States Distributing, LLC | Veterinary | 09/11/2023 | Document review entity's hazard analysis |
Mid-States Distributing, LLC | Veterinary | 09/11/2023 | Evaluation - performance, risk |
Mid-States Distributing, LLC | Veterinary | 09/11/2023 | Verification activity before import, periodically |
Morgan Newton Comp. | Devices | 05/12/2023 | Product rework adverse effects {see also 820.184} |
Morgan Newton Comp. | Devices | 05/12/2023 | DHR - not or inadequately maintained |
Mtek Group, LLC | Food and Cosmetics | 09/27/2023 | Approved supplier procedures - importer established |
Orthofix U. S., LLC | Devices | 03/17/2023 | Lack of or inadequate procedures |
Orthofix U. S., LLC | Devices | 03/17/2023 | Investigation of device failures |
Parvez Mantry | Drugs | 11/14/2023 | FD-1572, protocol compliance |
Post Oak Innovations, Inc. | Devices | 10/13/2023 | Document change records, maintained. |
Post Oak Innovations, Inc. | Devices | 10/13/2023 | Acceptable supplier records, inadequate records |
Post Oak Innovations, Inc. | Devices | 10/13/2023 | Lack of or inadequate procedures |
Premier Produce Services | Food and Cosmetics | 05/02/2023 | Supplier approval - document |
Premier Produce Services | Food and Cosmetics | 05/02/2023 | Onsite audit |
RP Foods, LLC | Food and Cosmetics | 07/06/2023 | Develop FSVP |
Renfro Foods, Inc. | Food and Cosmetics | 08/31/2023 | Process deviation |
Renfro Foods, Inc. | Food and Cosmetics | 08/31/2023 | Qualifications of individuals |
Select Corporation | Drugs | 09/14/2023 | Procedures To Be in Writing |
Select Corporation | Drugs | 09/14/2023 | Review of problem drugs |
Select Corporation | Drugs | 09/14/2023 | No written record of investigation |
Selery Fulfillment, Inc. | Food and Cosmetics | 04/12/2023 | Written procedures - cleaning |
Selery Fulfillment, Inc. | Food and Cosmetics | 04/12/2023 | Written procedures - pest control |
Selery Fulfillment, Inc. | Food and Cosmetics | 04/12/2023 | Reserve sample - collect, hold |
Selery Fulfillment, Inc. | Food and Cosmetics | 04/12/2023 | Written procedures - holding |
Selery Fulfillment, Inc. | Food and Cosmetics | 04/12/2023 | Hold - temperature, humidity, light |
Selery Fulfillment, Inc. | Food and Cosmetics | 04/12/2023 | Records - returned dietary supplement: written procedures |
Selery Fulfillment, Inc. | Food and Cosmetics | 04/12/2023 | Record - product complaint; batch, lot, control number |
SouQ El Sudan, Inc. | Food and Cosmetics | 09/08/2023 | Develop FSVP |
Taka USA, Inc. | Drugs | 02/07/2023 | Procedures not in writing, fully followed |
Taka USA, Inc. | Drugs | 02/07/2023 | Training--operations, GMPs, written procedures |
Taka USA, Inc. | Drugs | 02/07/2023 | Written procedures fail to include |
Taka USA, Inc. | Drugs | 02/07/2023 | Reports of Analysis (Components) |
Taka USA, Inc. | Drugs | 02/07/2023 | Control procedures to monitor and validate performance |
Taka USA, Inc. | Drugs | 02/07/2023 | Scientifically sound laboratory controls |
Taka USA, Inc. | Drugs | 02/07/2023 | Testing and release for distribution |
Taka USA, Inc. | Drugs | 02/07/2023 | Test methods |
Taka USA, Inc. | Drugs | 02/07/2023 | Prepared for each batch, include complete information |
Third Coast Marketing Holdings, LP | Food and Cosmetics | 08/03/2023 | Written procedures - quality control operations |
Third Coast Marketing Holdings, LP | Food and Cosmetics | 08/03/2023 | Written procedures - holding |
Third Coast Marketing Holdings, LP | Food and Cosmetics | 08/03/2023 | Written procedures - returned dietary supplement |
Third Coast Marketing Holdings, LP | Food and Cosmetics | 08/03/2023 | Written procedures - product complaint |
Third Coast Marketing Holdings, LP | Food and Cosmetics | 08/03/2023 | Quality control operations - packaging, labeling; approving, rejecting |
Unifi Aviation, LLC | Food and Cosmetics | 01/25/2023 | Handling to avoid contamination |
Yi Group, Inc. | Food and Cosmetics | 09/15/2023 | Develop FSVP |