# FDA 483 - Brookfield Medical/Surgical Supplies, Inc. - April 18, 2017

Source: https://www.keypedia.com/records/483/brookfield-medicalsurgical-supplies-inc/67f0dba0-54a2-49ed-8738-d7589591dd03

> FDA 483 for Brookfield Medical/Surgical Supplies, Inc. on April 18, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brookfield Medical/Surgical Supplies, Inc.
- Inspection Date: 2017-04-18
- Product Type: Drugs
- Office Name: New England District Office
- Summary: This FDA Form 483 details observations from an inspection, citing failures in quality control and aseptic processing at a facility manufacturing Betamethasone Sodium Phosphate, Methylprednisolone Acetate, and Triamcinolone Acetonide for Injection.

A primary violation is the failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. Specifically, two lots of Betamethasone Sodium Phosphate PF 6mg/mL were rejected due to low potency (89.7%, 89.01%). The firm's corrective action involved changing a component, but the impact on potency loss, degradation, impurities, and impurity limits was not evaluated. This is a repeat observation from a 2015 FDA-483, and the firm continues to manufacture and release these products.

Additionally, the firm failed to evaluate the impact of a component change on Methylprednisolone Acetate and Triamcinolone Acetonide Suspension for Injection. Two lots of Triamcinolone Acetonide 40mg/mL failed potency (119.7%/115.4%, 121.3%), with investigations failing to assess the component's impact. A Methylprednisolone Acetate 40mg/mL lot also failed potency (110.49%) due to a component issue, the impact of which remains unassessed.

The firm also lacks rationale for not investigating lots manufactured before and after

## Related Documents

- [483 - 2015-04-09](https://www.keypedia.com/records/483/brookfield-medicalsurgical-supplies-inc/8c3abf05-7b43-44ef-8f45-6dd4b0201880)
- [483 - 2017-04-18](https://www.keypedia.com/records/483/brookfield-medicalsurgical-supplies-inc/32b09fa8-3d36-432a-b841-569f5047e867)
- [483 - 2017-06-28](https://www.keypedia.com/records/483/brookfield-medicalsurgical-supplies-inc/12cff249-2d7a-4f55-8b76-8c89d459479d)
- [483 - 2018-12-21](https://www.keypedia.com/records/483/brookfield-medicalsurgical-supplies-inc/ca609037-e512-410e-bf9c-33541e0ea346)
- [483 - 2018-12-21](https://www.keypedia.com/records/483/brookfield-medicalsurgical-supplies-inc/8655c204-3c2f-4015-b35d-c739299ffdd9)

## Related Officers

- [Principal](https://www.keypedia.com/people/christopher-janik/2803fa51-5259-4632-93ad-c6f038bd2fd4)
- [Nealie C. Newberger](https://www.keypedia.com/people/nealie-c-newberger/4b7addde-1217-4495-bac2-2f7e3fe2e780)

Company: https://www.keypedia.com/companies/brookfield-medicalsurgical-supplies-inc/38913e9c-812d-4157-94ec-cab9401cbe73

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144