# FDA WARNING_LETTER - Sgarlato Laboratories - January 22, 2008

Source: https://www.keypedia.com/records/warning_letter/sgarlato-laboratories/62da4328-fe47-477a-8d75-52d053fc0b89

> FDA WARNING_LETTER for Sgarlato Laboratories on January 22, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sgarlato Laboratories
- Inspection Date: 2008-01-22
- Product Type: Devices
- Office Name: San Francisco District Office
- Summary: On August 27, 2008, the FDA issued a Warning Letter to Sgarlato Laboratories following an inspection from January 8-22, 2008, which found their Sgarlato Pain Free Pumps to be adulterated. The inspection revealed non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  **Failure to establish and maintain procedures for acceptance of incoming product (21 CFR 820.80(b))**: Sgarlato Laboratories could not provide receiving inspection documentation for multiple lots of Pain Free Pumps, and for some lots, testing was explicitly not performed to fulfill orders.
2.  **Failure to prevent distribution of expired devices (21 CFR 820.160(a))**: An expired Pain Free Pump kit (Lot 60772460) was shipped with the expiration date "blackened" out.
3.  **Failure to control labeling activities (21 CFR 820.120(b))**: Labels with extended expiration dates were affixed over manufacturer's labels without justification.
4.  **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)(3))**: A complaint for a leaking pump lacked sufficient information to

## Related Officers

- [Director ](https://www.keypedia.com/people/barbara-j-cassens/26dd2da1-417d-4913-9432-3d50fb3c2f40)
- [ Assistant Deputy Chief](https://www.keypedia.com/people/sergio-chavez/666c6fc6-b829-4865-b896-947ff3e114d5)
- [Thomas E. Sgarlato](https://www.keypedia.com/people/thomas-e-sgarlato/bcd53fa0-8f3a-48b4-a80c-b09b321e63d9)

Company: https://www.keypedia.com/companies/sgarlato-laboratories/b7f0cac0-428e-4bcd-90a9-fba211db58fe

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df