# FDA 483 - TMC Acquisitions LLC dba Tailor Made Compounding - March 14, 2022

Source: https://www.keypedia.com/records/483/tmc-acquisitions-llc-dba-tailor-made-compounding/e2eb1d93-76e0-4889-9351-a87fda05d806

> FDA 483 for TMC Acquisitions LLC dba Tailor Made Compounding on March 14, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TMC Acquisitions LLC dba Tailor Made Compounding
- Inspection Date: 2022-03-14
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in aseptic processing, environmental control, and quality systems.

**Facility and Operations:** The inspection covered sterile injectable drug product manufacturing in ISO 5, ISO 7, and ISO 8 cleanrooms, including compounding of Methylcobalamin, Calcium Chloride, Semaglutide/Cyanocobalamin, and other products.

**Violations and Observations:**

*   **Aseptic Manipulations (Observation 1):** Technicians repeatedly interrupted ISO 5 airflow by reaching over open units and having exposed skin (head) inside the ISO 5 hood during sterile product filling.
*   **Direct Product Contact (Observation 2):** Technicians manually touched the inner surface of sterile stoppers with gloved hands during vial filling for multiple batches, including those distributed to patients.
*   **Non-Microbial Contamination (Observation 3):** Apparent yellow staining on HEPA filter guard, rust on door trim and under ISO 5 hood benchtop, chipping/cracking walls, rusted box cutter, and residue buildup on countertops, floors, and equipment (wire rack, glass beaker) were observed in cleanrooms.
*   **Inadequate HEPA Filter Coverage (Observation 4):** Large light panels in ISO 5 hood ceilings broke up HEPA filter coverage, leading to sterile product exposure without adequate HEPA-filtered air.
*   **Improper

## Related Documents

- [483 - 2018-10-24](https://www.keypedia.com/records/483/tmc-acquisitions-llc-dba-tailor-made-compounding/56813102-76b7-4291-88c4-89c3f24546e2)

## Related Officers

- [Drug Specialist](https://www.keypedia.com/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)
- [Consumer Safety Officer , Investigator](https://www.keypedia.com/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)
- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)

Company: https://www.keypedia.com/companies/tmc-acquisitions-llc-dba-tailor-made-compounding/d8938656-ab1c-4b4a-95e0-6f3504973d2c

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c