There were nine companies in cities associated with Allegheny County that received FDA citations as a result of nine inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 200% increase over the number of companies cited in the previous year.
The citations in the county include:
- The organizational structure has not been adequately established and maintained to ensure that devices are produced in accordance with 21 CFR 820.
- Procedures to control labeling activities have not been adequately established.
- Labels were not printed so as to remain legible during processing, storage, handling, distribution, and/or use.
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 either Devices or Drugs sectors.
Of the companies cited, eight should take voluntary actions to correct their managing operations (88.9%). Additionally, one company had to take regulatory and/or administrative actions (11.1%).
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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Alejandro Hoberman, M.D. | Biologics | 06/18/2024 | Understandable language |
| Greco Gas, Inc. | Drugs | 04/05/2024 | Approve or reject components, products |
| Greco Gas, Inc. | Drugs | 04/05/2024 | GMP Training Frequency |
| Greco Gas, Inc. | Drugs | 04/05/2024 | Written calibration / inspection records not kept |
| Greco Gas, Inc. | Drugs | 04/05/2024 | Reports of Analysis (Components) |
| Greco Gas, Inc. | Drugs | 04/05/2024 | Calibration – at intervals, written program, remedial action |
| Greco Gas, Inc. | Drugs | 04/05/2024 | Testing and release for distribution |
| Greco Gas, Inc. | Drugs | 04/05/2024 | Identification of each component or in-process material |
| Greco Gas, Inc. | Drugs | 04/05/2024 | Investigations of discrepancies, failures |
| Greco Gas, Inc. | Drugs | 04/05/2024 | Test results, comparison with standards not included |
| Ionetix Corporation | Drugs | 01/19/2024 | Contact surfaces |
| Kervan USA, LLC | Food and Cosmetics | 09/11/2024 | Develop FSVP |
| La Prima Espresso Company | Food and Cosmetics | 09/24/2024 | Personnel |
| La Prima Espresso Company | Food and Cosmetics | 09/24/2024 | Food safety plan |
| Nasorcap Medical, Inc. | Devices | 01/22/2024 | Lack of or inadequate organizational structure |
| Nasorcap Medical, Inc. | Devices | 01/22/2024 | Quality System Procedures |
| Pittsburgh Spice & Seasoning Company, Inc. | Food and Cosmetics | 08/26/2024 | Hazard analysis – Identification of hazard |
| Pittsburgh Spice & Seasoning Company, Inc. | Food and Cosmetics | 08/26/2024 | Preventive controls records – General requirements |
| Pittsburgh Spice & Seasoning Company, Inc. | Food and Cosmetics | 08/26/2024 | Supply-chain program – Assurance (Adequate) |
| Pittsburgh Spice & Seasoning Company, Inc. | Food and Cosmetics | 08/26/2024 | Supply-chain program – Supplier approval |
| SEKO MedTec Solutions | Devices | 07/08/2024 | Lack of or inadequate organizational structure |
| SEKO MedTec Solutions | Devices | 07/08/2024 | Lack of or inadequate procedures for labeling |
| SEKO MedTec Solutions | Devices | 07/08/2024 | Remain legible |
| SEKO MedTec Solutions | Devices | 07/08/2024 | Examination for accuracy |
| Smart Juice, LLC | Food and Cosmetics | 12/04/2024 | Investigate |
