# FDA 483 - Summers Laboratories Inc. - December 28, 2012

Source: https://www.globalkeysolutions.net/records/483/summers-laboratories-inc/b9bfe8a5-472f-4604-b0a8-8e03d5a63f8f

> FDA 483 for Summers Laboratories Inc. on December 28, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Summers Laboratories Inc.
- Inspection Date: 2012-12-28
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Summers Laboratories, Inc. in Collegeville, PA, an own label finished drug distributor, was inspected from December 18-28, 2012. The inspection revealed significant deficiencies across multiple quality system elements, including inadequate complaint investigations, lack of proper quality unit procedures and change control, insufficient stability testing, and improper storage conditions for drug products. These findings indicate a systemic failure to adhere to good manufacturing practices for drug product distribution and quality control.

## Related Officers

- [Senior Mutual Recognition Program Officer](https://www.globalkeysolutions.net/people/julianne-c-mccullough/87873501-94b3-4eee-8d67-5d241cb9bbf9)

Company: https://www.globalkeysolutions.net/companies/summers-laboratories-inc/20edf43c-7b37-49a4-bccd-1a0ba43acbf6

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