There were 13 companies in cities associated with Middlesex County that received FDA citations as a result of 13 inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 44.4% increase over the number of companies cited in the previous year.
Of the 30 citations issued, the most common citation was ‘You did not develop an FSVP’.
Most of the companies cited were involved in the Drugs sector. The second most common type of company operated in the Food and Cosmetics sector.
All of the companies cited should take voluntary actions to correct their managing operations.
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.
According to its website, 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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| B. P. Nanak Import, Inc. | Food and Cosmetics | 01/28/2025 | Develop FSVP |
| B. P. Nanak Import, Inc. | Food and Cosmetics | 01/28/2025 | Document review entity’s hazard analysis |
| B. P. Nanak Import, Inc. | Food and Cosmetics | 01/28/2025 | Supplier approval – document |
| B. P. Nanak Import, Inc. | Food and Cosmetics | 01/28/2025 | Approved supplier procedures – importer established |
| B. P. Nanak Import, Inc. | Food and Cosmetics | 01/28/2025 | Supplier verification – establish written procedures |
| Biocon Generics, Inc. | Drugs | 10/10/2025 | Written warehousing procedures established/followed |
| Cosmax USA, Corporation | Drugs | 09/12/2025 | Valid stability test methods |
| Endo USA, Inc. | Drugs | 01/17/2025 | Scientifically sound laboratory controls |
| Henry’s United, LLC | Food and Cosmetics | 03/17/2025 | Develop FSVP |
| Henry’s United, LLC | Food and Cosmetics | 03/17/2025 | Hazard analysis biological, chemical, physical |
| Henry’s United, LLC | Food and Cosmetics | 03/17/2025 | Evaluation – performance, risk |
| Henry’s United, LLC | Food and Cosmetics | 03/17/2025 | Verification activity before import, periodically |
| Invahealth, Inc. | Drugs | 11/21/2025 | Buildings not maintained in good state of repair |
| Invahealth, Inc. | Drugs | 11/21/2025 | Scientifically sound laboratory controls |
| Le Papillon, Ltd. | Drugs | 06/05/2025 | Procedures not in writing, fully followed |
| Le Papillon, Ltd. | Drugs | 06/05/2025 | Cleaning / Sanitizing / Maintenance |
| Le Papillon, Ltd. | Drugs | 06/05/2025 | Absence of Written Procedures |
| Loving Pets, Corp. | Veterinary | 01/27/2025 | Preventive Controls |
| Loving Pets, Corp. | Veterinary | 01/27/2025 | Supply-Chain Appropriate Verification Activities |
| Moldworks Worldwide, LLC | Devices | 12/09/2025 | Quality audits – Lack of or inadequate procedures |
| Moldworks Worldwide, LLC | Devices | 12/09/2025 | Training records |
| Moldworks Worldwide, LLC | Devices | 12/09/2025 | Purchasing controls, Lack of or inadequate procedures |
| Moldworks Worldwide, LLC | Devices | 12/09/2025 | Acceptance status |
| N & J Bread | Food and Cosmetics | 05/20/2025 | Personnel |
| N & J Bread | Food and Cosmetics | 05/20/2025 | Pest control |
| N & J Bread | Food and Cosmetics | 05/20/2025 | Equipment and utensils – Design and maintenance |
| Surati Sweet Mart II, LLC | Food and Cosmetics | 04/04/2025 | Develop FSVP |
| Tris Pharma, Inc. | Drugs | 11/21/2025 | Investigations of discrepancies, failures |
| Tulex Pharmaceuticals, Inc. | Drugs | 03/24/2025 | Scientifically sound laboratory controls |
| Tulex Pharmaceuticals, Inc. | Drugs | 03/24/2025 | Investigations of discrepancies, failures |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
