# FDA 483 - Med Shop Total Care Inc. - November 01, 2018

Source: https://www.keypedia.com/records/483/med-shop-total-care-inc/f6b6d663-49ce-4af7-a8a0-9828c009d9ba

> FDA 483 for Med Shop Total Care Inc. on November 01, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Med Shop Total Care Inc.
- Inspection Date: 2018-11-01
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details numerous deficiencies at a facility manufacturing sterile and non-sterile drug products, including veterinary and human intrathecal products.

**Environmental Monitoring & Aseptic Processing:**
* Aseptic processing areas lack adequate environmental monitoring systems.
* Microorganisms from environmental and fingertip monitoring were not identified, and production continued without complete investigations or corrective actions.
* Procedures for environmental monitoring are deficient, lacking microorganism impact assessment and specific sampling locations.
* Only viable and non-viable particulates are monitored, and a qualified individual for plate reading is absent.
* Media fills do not simulate worst-case conditions, omitting smallest/largest batch sizes and different container types.
* Smoke studies under dynamic conditions in ISO 5 areas are not performed, with the observed study only demonstrating pulling drug product from a vial into a syringe.

**Product Testing & Quality Control:**
* Sterile drug products are not tested for objectionable microorganisms or pyrogens.
* Endotoxin analysis is absent for sterile veterinary stock solutions, and the human sterile stock solution endotoxin test method is non-compendial.
* No endotoxin testing is conducted for finished sterile drug products, including intrathecal products containing Morphine Sulfate, Bupivacaine, Fentanyl, Clonidine, Baclofen, or Hydromorphone.
* Finished product release testing does not include identity and strength determination for active ingredients.
* Testing results for veterinary products are not documented.

## Related Documents

- [WARNING_LETTER - 2018-11-01](https://www.keypedia.com/records/warning_letter/med-shop-total-care-inc/8a1b6046-6f6f-40e0-91f5-47563c7e39c0)
- [483 - 2021-07-27](https://www.keypedia.com/records/483/med-shop-total-care-inc/5169873a-2d37-4cf5-bd30-070f6173ab8e)
- [483 - 2023-06-08](https://www.keypedia.com/records/483/med-shop-total-care-inc/a17cde0f-38a6-447a-b406-58bf394660b8)

## Related Officers

- [CO CDER OMQ](https://www.keypedia.com/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

Company: https://www.keypedia.com/companies/med-shop-total-care-inc/8dcec214-6b07-4aaa-98d6-37f967aa2794

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9