# FDA 483 - Guardian Drug Co. Inc. - February 17, 2022

Source: https://www.keypedia.com/records/483/guardian-drug-co-inc/3e39ebe5-e5aa-4ada-9a26-3461fed7fd81

> FDA 483 for Guardian Drug Co. Inc. on February 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guardian Drug Co. Inc.
- Inspection Date: 2022-02-17
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Guardian Drug Co. Inc. in Dayton, NJ, a drug manufacturer, revealed significant deficiencies across multiple areas. The firm was cited for inadequate laboratory controls, failure to thoroughly investigate out-of-specification results, insufficient quality unit review of production records, and unvalidated equipment cleaning procedures. These issues indicate a lack of robust quality systems necessary to ensure drug product quality and purity.

## Related Documents

- [EIR - 2022-02-17](https://www.keypedia.com/records/eir/guardian-drug-co-inc/6571461b-3600-4653-a3f3-1a632c428ad3)

## Related Officers

- [Consumer Safety Officer at FDA U.S. Food and Drug Administration](https://www.keypedia.com/people/ko-u-min/9bb5f33e-857b-4c6f-a550-fdb439760e30)
- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

Company: https://www.keypedia.com/companies/guardian-drug-co-inc/da99310b-93a6-472f-be75-5d50ada01579

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248