# FDA 483 - Garda Rx LLC - June 06, 2017

Source: https://www.keypedia.com/records/483/garda-rx-llc/631863ea-a03a-46cd-8fcf-f94ee425063a

> FDA 483 for Garda Rx LLC on June 06, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Garda Rx LLC
- Inspection Date: 2017-06-06
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: On June 6, 2017, the FDA issued a Form 483 to Garda Rx LLC, located at 1596 Hancock Ave, Apollo, PA 15613-8404, following an inspection conducted from June 1-6, 2017. The inspection was of a producer of non-sterile drugs, and the report was issued to Martin J. Garda, President and Owner.

The inspection revealed insanitary conditions during the production of non-sterile drug products. Specifically, the (b)(4) countertop used for production had exposed particle board on a side adjacent to the work surface. Additionally, visible residues and filth were observed adjacent to the non-sterile production area on a shelf holding non-sterile production equipment, on the balance used for non-sterile drug product production, and in the (b)(4) used for non-sterile drug product production. These observations indicate deficiencies in maintaining a clean and sanitary environment for drug manufacturing.

## Related Documents

- [STATE_REFERRAL_LETTER - 2017-06-01](https://www.keypedia.com/records/state_referral_letter/garda-rx-llc/d8d469dc-b825-4524-b988-e5ba97bca27d)

## Related Officers

- [Juan R. Jimenez Garcia](https://www.keypedia.com/people/juan-r-jimenez-garcia/c0f9553c-9060-4512-b51e-792d2dccacfe)

Company: https://www.keypedia.com/companies/garda-rx-llc/46f7b076-a376-4dd0-8dfd-158b7a8544eb

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