# FDA 483 - TMC Acquisitions LLC dba Tailor Made Compounding - October 24, 2018

Source: https://www.keypedia.com/records/483/tmc-acquisitions-llc-dba-tailor-made-compounding/56813102-76b7-4291-88c4-89c3f24546e2

> FDA 483 for TMC Acquisitions LLC dba Tailor Made Compounding on October 24, 2018. 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: 2018-10-24
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: This FDA Form 483 details observations from an inspection of a facility involved in sterile drug product manufacturing. The facility has documented five sterility failures since January 2016.

Key observations include:
- **Inadequate Investigations:** Investigations into unexplained discrepancies and batch failures did not extend to other potentially associated batches or drug products.
- **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination are not established or followed. A pharmacy technician was observed entering an ISO 7 room with ungloved hands before applying sanitizer and sterile gloves.
- **Aseptic Processing Area Deficiencies:**
    - Systems for maintaining equipment used to control aseptic conditions are deficient.
    - Cleaning and disinfecting systems are deficient; a non-sterile bactericidal agent is used for cleaning ISO 5, 7, and 8 rooms.
    - Environmental monitoring is deficient, with personnel monitoring only conducted every (b)(4) and limited to fingertips, without documenting the time of monitoring or monitoring other areas.
- **Labeling Control Issues:** Incorrect Beyond Use Dates (BUD) were observed on Tesamorelin 1 mg subcutaneous injection vials (batch 07161804), showing a one-year BUD instead of the correct 180 days.
- **Product Release and Testing:**
    - Potency testing is performed at random intervals with no set schedule, and three products with Out-of-Specification (OOS) potency results were

## Related Documents

- [483 - 2022-03-14](https://www.keypedia.com/records/483/tmc-acquisitions-llc-dba-tailor-made-compounding/e2eb1d93-76e0-4889-9351-a87fda05d806)

## Related Officers

- [Nicholas L. Paulin](https://www.keypedia.com/people/nicholas-l-paulin/a8e0649a-614f-499b-8fdc-1217f7d71887)
- [General Manager](https://www.keypedia.com/people/michael-p-sheehan/bb91f6d2-e3fb-488f-a502-7039f556449f)

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

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22