# FDA 483 - Fragrance Manufacturing, Inc. dbs FMI - September 14, 2022

Source: https://www.keypedia.com/records/483/fragrance-manufacturing-inc-dbs-fmi/f422ea9c-5a1d-4e0b-b556-d85e472098b5

> FDA 483 for Fragrance Manufacturing, Inc. dbs FMI on September 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fragrance Manufacturing, Inc. dbs FMI
- Inspection Date: 2022-09-14
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Fragrance Manufacturing, Inc. dba FMI in Allentown, PA, received a Form 483 with three repeat observations during an inspection from September 12-14, 2022. The firm was cited for significant deficiencies in its production and process controls, including a lack of process validation and hold time studies for OTC drug products. Additionally, the inspection revealed a failure to establish written procedures for equipment cleaning and maintenance, as well as a lack of equipment qualification and validation data.

## Related Officers

- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.keypedia.com/companies/fragrance-manufacturing-inc-dbs-fmi/928e81c4-65b1-4945-8649-bce04b698cfb

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8