# FDA 483 - Savings Distributors LLC - August 27, 2020

Source: https://www.globalkeysolutions.net/records/483/savings-distributors-llc/961ee4a3-5513-4682-9a81-54fe0de93bdd

> FDA 483 for Savings Distributors LLC on August 27, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Savings Distributors LLC
- Inspection Date: 2020-08-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Savings Distributors LLC, a drug repacker in Islandia, NY, was inspected by the FDA from August 24-27, 2020. The inspection revealed significant deficiencies across multiple areas, including failures in quality control unit procedures, lack of written production controls, and inadequate employee training. Further issues included the absence of stability testing, incomplete batch records, insufficient storage areas, improper temperature control for drug products, and failures in sampling and examining packaging materials and retaining reserve samples, indicating a broad lack of adherence to cGMP requirements.

## Related Documents

- [483 - 2024-12-19](https://www.globalkeysolutions.net/records/483/savings-distributors-llc/3cf32e69-6f53-4283-a478-40db12a143bc)

## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.globalkeysolutions.net/companies/savings-distributors-llc/72c49639-6777-44cd-80b4-563f9377c783

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