# FDA 483 - Ecometics, Inc. - September 07, 2018

Source: https://www.keypedia.com/records/483/ecometics-inc/14ddb739-c80f-4b7d-bc2b-bbe806f603c2

> FDA 483 for Ecometics, Inc. on September 07, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ecometics, Inc.
- Inspection Date: 2018-09-07
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Ecocetics, Inc. in Norwalk, CT, an Rx and OTC drug manufacturer, received a Form 483 with nine observations. The inspection revealed significant deficiencies in contamination prevention, environmental controls for drug storage, equipment cleaning and validation, analytical method validation, and stability testing programs. Several observations were repeats, indicating persistent issues with maintaining appropriate manufacturing conditions and quality control for drug products.

## Related Documents

- [WARNING_LETTER - 2018-09-07](https://www.keypedia.com/records/warning_letter/ecometics-inc/40ef96e6-793e-4a58-ae25-700cb55cb090)
- [483 - 2021-09-10](https://www.keypedia.com/records/483/ecometics-inc/cc6a6bc9-409c-48dc-97a3-0bd2412fda61)
- [483 - 2023-02-06](https://www.keypedia.com/records/483/ecometics-inc/1cd34a16-eff2-4ae8-81d6-31c82f61aef4)

## Related Officers

- [Director, Team Biologics Staff](https://www.keypedia.com/people/helen-b-ricalde/455f022e-4d32-453e-acc7-e84a53ce730c)

Company: https://www.keypedia.com/companies/ecometics-inc/83e2f2bc-9707-4ffc-9f49-ee6de57d5935

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94