# FDA 483 - Maitland Labs of Central Florida - February 28, 2020

Source: https://www.keypedia.com/records/483/maitland-labs-of-central-florida/a92f9111-5b8b-47d8-8167-bf2bf45ac44c

> FDA 483 for Maitland Labs of Central Florida on February 28, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maitland Labs of Central Florida
- Inspection Date: 2020-02-28
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: The FDA Form 483 details multiple deficiencies at an outsourcing facility producing sterile drug products, specifically Nalbuphine HCL, 10mg/1mL.

**Aseptic Processing & Environmental Control:**
*   Aseptic processing areas are deficient in cleaning and disinfection. Non-sterile disinfectant and wipes are used in the Cleanroom and ISO 5 Laminar Flow Hood, and sterile wipes shed particulates.
*   The firm failed to conduct a smoke study under dynamic conditions within the ISO-5 Laminar Flow Hood used for Nalbuphine HCL production.

**Quality System & Investigations:**
*   The firm failed to thoroughly review unexplained discrepancies. Specifically, 93 vials of Nalbuphine HCL, lot #20200108, failed visual inspection for fibers, but no investigation or corrective actions were taken.
*   Alarms (exhaust rate too fast, door unsealed) on the lyophilizer during processing of Nalbuphine HCL, lot #20200108, were not evaluated for their impact on the batch, despite subsequent maintenance.

**Stability & Testing:**
*   There is no written stability testing program. The firm failed to follow appropriate stability requirements (temperature/humidity) for Nalbuphine HCL, lot #2019111 R&D, lacking data to support a 12-month expiration date for lot #202001

## Related Documents

- [483 - 2019-06-17](https://www.keypedia.com/records/483/maitland-labs-of-central-florida/8685563e-fd45-45de-a665-cdecdad87f8a)
- [WARNING_LETTER - 2020-02-28](https://www.keypedia.com/records/warning_letter/maitland-labs-of-central-florida/8f48a51c-15e4-44c9-9b40-ebefbd55a6a5)

## Related Officers

- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.keypedia.com/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)

Company: https://www.keypedia.com/companies/maitland-labs-of-central-florida/2f1ad5f0-e6b8-4936-801a-736dea9ad130

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9