# FDA 483 - Pharmalab Enterprises, Inc. - June 17, 2019

Source: https://www.keypedia.com/records/483/pharmalab-enterprises-inc/6f8292bd-0ec6-4bd7-a5d2-343fc2593b53

> FDA 483 for Pharmalab Enterprises, Inc. on June 17, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmalab Enterprises, Inc.
- Inspection Date: 2019-06-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Pharmalab Enterprises, Inc. in Hialeah, FL, a manufacturer of liquid OTC drugs, dietary supplements, and medical foods, was cited for significant deficiencies across its operations. The inspection revealed inadequate laboratory controls, including deficient specifications and failure to investigate discrepancies, as well as poor production practices such as insufficient process validation and equipment maintenance. Additionally, the firm failed to conduct proper testing for dietary ingredients and finished products, lacked adequate contamination controls, and had uncalibrated instruments for medical food production.

## Related Documents

- [WARNING_LETTER - 2019-06-17](https://www.keypedia.com/records/warning_letter/pharmalab-enterprises-inc/4f359ab3-8dde-442b-8216-d32a423372ee)
- [483 - 2021-08-20](https://www.keypedia.com/records/483/pharmalab-enterprises-inc/b184dd3a-5880-4d86-a948-9e196b352c5f)

## Related Officers

- [Anabel Veiga](https://www.keypedia.com/people/anabel-veiga/14b0cb91-1346-44c1-8f79-2549bb6bf221)
- [investigator](https://www.keypedia.com/people/lissette-paiz/3d6c9613-59f6-4998-996a-93500997140f)
- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.keypedia.com/companies/pharmalab-enterprises-inc/27b5c569-e0be-41a5-a4ed-23b7f2c4d56c

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6