# FDA 483 - Time-Cap Laboratories, Inc. - December 18, 2019

Source: https://www.keypedia.com/records/483/time-cap-laboratories-inc/3fc2a7d3-8c0a-447c-ac6c-8a8efcd50178

> FDA 483 for Time-Cap Laboratories, Inc. on December 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Time-Cap Laboratories, Inc.
- Inspection Date: 2019-12-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Time-Cap Laboratories, Inc. in Farmingdale, NY, a drug manufacturer and repackager, received a Form FDA 483 with three observations during an inspection from December 5-18, 2019. The firm was cited for inadequate cleaning validation processes for shared equipment, a lack of written procedures for the quality control unit, and failures in reviewing and investigating unexplained discrepancies and audit trail actions. These findings highlight significant concerns regarding the firm's adherence to Good Manufacturing Practices and data integrity.

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## Related Officers

- [investigator](https://www.keypedia.com/people/jay-wong/d58065c6-6c52-4d77-af6b-089176c778c9)

Company: https://www.keypedia.com/companies/time-cap-laboratories-inc/6171549a-9909-4458-ad55-726353db4fc3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961